FHIR Server FHIR Server Version n/a

Resource Questionnaire/FHIR Server from package hl7.fhir.us.sirb#current (641 ms)

Package
hl7.fhir.us.sirb
Type
Questionnaire
FHIR Version
Source
http://hl7.org/fhir/us/sirb/https://build.fhir.org/ig/HL7/fhir-sirb/Questionnaire-sirb-initiate-study-questionnaire-populate.html
Url
http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate
Version
1.0.0
Status
draft
Date
2023-04-24T20:03:27+00:00
Name
SIRBInitiateAStudyQuestionnaire
Title
Initiate a Study Questionnaire
Experimental
False
Realm
Authority
hl7
Description
Initiate a Study Questionnaire
Resources that use this resource

No resources found
Resources that this resource uses

No resources found
Narrative

Note: links and images are rebased to the (stated) source
Structure
LinkId	Text	Cardinality	Type	Description & Constraints
SIRBInitiateAStudyQuestionnaire	Initiate a Study Questionnaire		Questionnaire	http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate#1.0.0
in1	Research Study Details	0..1	group
in1.1	Study Title	1..1	string
in1.1_help	The official title of a protocol used to identify a clinical study.Include phase (e.g. pilot proof of concept study, phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc.), if the study is multi-center, the investigational agent (drug, device, biologic, vaccine, procedural and/or behavioral etc., and target disease(s)	0..1	display
in1.2	Study Title (Short)	1..1	string
in1.2_help	A short study title written in language intended for the lay public.	0..1	display
in1.3	IRB Protocol Number	1..1	string
in1.3_help	The Protocol Number assigned by the sIRB	0..1	display
in1.4	Study Type	1..1	choice	Options: 2 options
in1.4_help	Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)	0..1	display
DIVIDER1	null	0..1	display
in5	Other Organization(s) Involved	0..*	group
in5.1	Relationship Type	1..1	choice	Options: 2 options
in5.1_help	Select the organization's type of involvement in the study	0..1	display
in5.2	Organization Name	1..1	string
in5.2_help	e.g. NIH or company name	0..1	display
in5.3	Phone	0..1	string
in5.3_help	10 digit phone number, including area code	0..1	display
in5.4	Sponsor or Funding Source Protocol Number, if applicable	0..1	string
in5.4_help	Unique Protocol Identification Number used by the sponsor, if applicable	0..1	display
in5.5	Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)	0..1	string	Expressions: Calculated Value: `%combinedOtherOrgUniqueOneRepetition`
in5.6	Protocol Number with Organization Name (read-only)	0..1	string	Expressions: Calculated Value: `%otherOrgProtocolWithNameOneRepetition`
DIVIDER2	null	0..1	display
in6	sIRB (Reviewing Institution)	0..1	group
in6.1	sIRB (Reviewing Institution) Name	1..1	string
in6.1_help	Name of the sIRB (Reviewing Institution)	0..1	display
in6.10	Department Name or Division	0..1	string
in6.10_help	The department name or division of the sIRB, if applicable	0..1	display
in6.3	Institution Street Address	1..1	string
in6.3_help	Physical address of the sIRB (Reviewing Institution)	0..1	display
in6.4	Institution City	1..1	string
in6.5	Institution State	1..1	string
in6.6	Institution Zip Code	1..1	string
in6.7	Institution Country	0..1	string	Initial Value: string = United States
in6.8	Is a Federal Wide Assurance (FWA) Number assigned?	1..1	choice	Options: 4 options
in6.8_help	DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".	0..1	display
in6.9	Federal Wide Assurance Number (if assigned)	0..1	integer	Enable When: in6.8 = Yes (expandedYes-NoIndicator#Y)
in6.9_help	If assigned, enter just numeric value of FWA.	0..1	display
in6.11	Is the sIRB a 3rd party institution?	0..1	choice	Options: 2 options
in6.11_help	Is the sIRB an external 3rd party institution, outside of the lead Principal Investigator institution?	0..1	display
DIVIDER3	null	0..1	display
in7	Lead Principal Investigator	0..1	group
in7.1	Lead Principal Investigator Institution	0..1	group
in7.1.1	Lead Principal Investigator Institution Name	1..1	string
in7.1.1_help	Name of institution for the lead principal investigator	0..1	display
in7.1.10	Department Name or Division	0..1	string
in7.1.10_help	The department name or division of the lead principal investigator	0..1	display
in7.1.3	Institution Phone	0..1	string
in7.1.3_help	10-digit phone number, including area code, for the institution of the lead principal investigator	0..1	display
in7.1.4	Is a Federal Wide Assurance (FWA) Number assigned?	1..1	choice	Options: 4 options
in7.1.4_help	DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".	0..1	display
in7.1.5	Federal Wide Assurance Number (if assigned)	0..1	integer	Enable When: in7.1.4 = Yes (expandedYes-NoIndicator#Y)
in7.1.5_help	If assigned, enter just numeric value of FWA.	0..1	display
in7.3	Lead Principal Investigator	0..1	group
in7.3.1	Lead Principal Investigator First Name	1..1	string
in7.3.1_help	First Name or Given Name of the lead PI responsible for the overall study	0..1	display
in7.3.2	Lead Principal Investigator Last Name	1..1	string
in7.3.2_help	Last name, surname or family name of the lead PI responsible for the overall study	0..1	display
in7.3.3	Lead Principal Investigator Suffix	0..1	string
in7.3.3_help	Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.	0..1	display
in7.3.4	Academic and Professional Degrees associated with the Lead Principal Investigator	1..1	string
in7.3.4_help	Academic and Professional degrees associated with the lead principal investigator	0..1	display
in7.3.10	Department Name or Division	0..1	string
in7.3.10_help	The department name or division of the lead PI	0..1	display
in7.3.5	Phone	0..1	string
in7.3.5_help	10-digit phone number, including area code, for the lead principal investigator	0..1	display
in7.3.6	Email address	0..1	string
in7.3.6_help	Email address associated with the lead principal investigator	0..1	display
in7.3.7	Address of Lead Principal Investigator	0..1	group
in7.3.7.1	Street Address	0..1	string
in7.3.7.1_help	Physical address	0..1	display
in7.3.7.2	City	1..1	string
in7.3.7.3	State	1..1	string
in7.3.7.4	Zip Code	0..1	string
in7.3.7.5	Country	0..1	string	Initial Value: string = United States
in7.9	Lead Principal Investigator Unique Site (read-only)	0..1	string	Expressions: Calculated Value: `%combinedLeadPIUniqueSite`
in7.10	Lead Principal Investigator Full Name, Suffix and Degrees	0..1	string	Expressions: Calculated Value: `%fullNameDSLeadPI`
DIVIDER4	null	0..1	display
in8	Relying Site(s)	0..*	group
in8.5	Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator	0..1	group
in8.5.1	Is this relying site at the same institution as where the lead principal investigator is conducting the study?	0..1	choice	Options: 2 options
in8.5.1_help	This question is optional. It can be used to pre-populate the lead principal investigator institution details if this relying site is at the same institution as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.	0..1	display
in8.5.2	Is this relying site at the same site as where the lead principal investigator is conducting the study?	0..1	choice	Enable When: in8.5.1 = Yes (expandedYes-NoIndicator#Y) Options: 2 options
in8.5.2_help	This question is optional. It can be used to pre-populate the lead principal investigator site details if this relying site is at the same site as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.	0..1	display
in8.5.3	Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?	0..1	choice	Options: 2 options
in8.5.3_help	This question is optional. It can be used to pre-populate the lead principal investigator details if this relying site PI is the same PI as the lead principal investigator conducting the study. If you do not want pre-population to occur, you may leave this question blank.	0..1	display
in8.5.4	Is this relying site also considered to be the lead site for the study?	1..1	choice	Options: 2 options
in8.5.4_help	Indicator that the lead PI site where the study is being conducted is also participating as this relying site	0..1	display
in8.1	Relying Site Institution	0..1	group
in8.1.1	Relying Institution Name	1..1	string	Expressions: Calculated Value: `iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.1').answer.value)`
in8.1.1_help	Name of Institution for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions.	0..1	display
in8.1.10	Department Name or Division	0..1	string	Expressions: Calculated Value: `iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.10').answer.value)`
in8.1.10_help	The department name or division for the relying site	0..1	display
in8.1.3	Relying Institution Phone	0..1	string	Expressions: Calculated Value: `iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.3').answer.value)`
in8.1.3_help	10-digit phone number, including area code, for the relying institution	0..1	display
in8.1.4	Is a Federal Wide Assurance (FWA) Number assigned?	1..1	choice	Options: 4 options Expressions: Calculated Value: `iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.4').answer.valueCoding)`
in8.1.4_help	DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select "temporarily unavailable". If the user does not know if there is a FWA number assigned, select "No Information".	0..1	display
in8.1.5	Federal Wide Assurance Number (if assigned)	0..1	integer	Enable When: in8.1.4 = Yes (expandedYes-NoIndicator#Y) Expressions: Calculated Value: `iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.5').answer.value)`
in8.1.5_help	If assigned, enter just numeric value of FWA.	0..1	display
in8.1.6	Reliance Status	1..1	choice	Options: 5 options
in8.1.6_help	Status of the reliance agreement	0..1	display
in8.1_help	Institution whose IRB agrees to rely on oversite by the sIRB (Reviewing IRB)	0..1	display
in8.3	Relying Site Principal Investigator	0..1	group
in8.3.1	Relying Site Principal Investigator First Name	1..1	string	Expressions: Calculated Value: `iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.1').answer.value)`
Documentation for this format
Option Sets
Answer options for in1.4
http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#INT ("Interventional")
http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#OBS ("Observational")
Answer options for in5.1
http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#SFS ("Sponsor or Funding Source")
http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#CRO ("Contract Research Organization (CRO)")
Answer options for in6.8
http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
http://terminology.hl7.org/CodeSystem/v2-0532#NI ("No Information")
http://terminology.hl7.org/CodeSystem/v2-0532#NAV ("temporarily unavailable")
Answer options for in6.11
http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
Answer options for in7.1.4
http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
http://terminology.hl7.org/CodeSystem/v2-0532#NI ("No Information")
http://terminology.hl7.org/CodeSystem/v2-0532#NAV ("temporarily unavailable")
Answer options for in8.5.1
http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
Answer options for in8.5.2
http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
Answer options for in8.5.3
http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
Answer options for in8.5.4
http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
Answer options for in8.1.4
http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
http://terminology.hl7.org/CodeSystem/v2-0532#NI ("No Information")
http://terminology.hl7.org/CodeSystem/v2-0532#NAV ("temporarily unavailable")
Answer options for in8.1.6
http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#APPROVED ("Approved for reliance")
http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DENIED ("Denied reliance")
http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#POSSIBLE ("Potential/possible")
http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#CANCELLED ("Cancelled or not participating")
http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#ONHOLD ("Temporarily on hold")
Answer options for in9.1
http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
Answer options for in9.2
http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")
Answer options for in9.4
http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IND ("IND")
http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IDE ("IDE")
Source

{
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  "id" : "sirb-initiate-study-questionnaire-populate",
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text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"The type of the item\">Type</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"Other attributes of the item\">Flags</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"Additional information about the item\">Description &amp; Constraints</a><span style=\"float: right\"><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_q_root.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"QuestionnaireRoot\" class=\"hierarchy\"/> SIRBInitiateAStudyQuestionnaire</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Initiate a Study Questionnaire</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Questionnaire</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate#1.0.0</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" id=\"item.in1\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> in1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Research Study Details</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in1.1\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in1.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study Title</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" id=\"item.in1.1_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in1.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">The official title of a protocol used to identify a clinical study.Include phase (e.g. pilot proof of concept study, phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc.), if the study is multi-center, the investigational agent (drug, device, biologic, vaccine, procedural and/or behavioral etc., and target disease(s)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in1.2\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in1.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study Title (Short)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" id=\"item.in1.2_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in1.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">A short study title written in language intended for the lay public.</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in1.3\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in1.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">IRB Protocol Number</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" id=\"item.in1.3_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in1.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">The Protocol Number assigned by the sIRB</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)\" id=\"item.in1.4\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> in1.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study Type</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.in1.4\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)\" id=\"item.in1.4_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in1.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" id=\"item.DIVIDER1\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> DIVIDER1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">null</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" id=\"item.in5\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> in5</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Other Organization(s) Involved</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in5.1\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> in5.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Relationship Type</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.in5.1\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" id=\"item.in5.1_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in5.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Select the organization's type of involvement in the study</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in5.2\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in5.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Organization Name</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" id=\"item.in5.2_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in5.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">e.g. NIH or company name</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in5.3\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in5.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Phone</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" id=\"item.in5.3_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in5.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">10 digit phone number, including area code</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in5.4\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in5.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Sponsor or Funding Source Protocol Number, if applicable</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" id=\"item.in5.4_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in5.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Unique Protocol Identification Number used by the sponsor, if applicable</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" id=\"item.in5.5\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in5.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/questionnaire-definitions.html#Questionnaire.item.readOnly\" title=\"Is Readonly\"><img src=\"icon-qi-readonly.png\" alt=\"icon\"/></a><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\" alt=\"icon\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Expressions: <ul><li style=\"font-size: 11px\"><a href=\"http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression\">Calculated Value</a>: <code>%combinedOtherOrgUniqueOneRepetition</code></li></ul></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)\" id=\"item.in5.6\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in5.6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Protocol Number with Organization Name (read-only)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/questionnaire-definitions.html#Questionnaire.item.readOnly\" title=\"Is Readonly\"><img src=\"icon-qi-readonly.png\" alt=\"icon\"/></a><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\" alt=\"icon\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Expressions: <ul><li style=\"font-size: 11px\"><a href=\"http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression\">Calculated Value</a>: <code>%otherOrgProtocolWithNameOneRepetition</code></li></ul></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" id=\"item.DIVIDER2\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> DIVIDER2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">null</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" id=\"item.in6\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> in6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">sIRB (Reviewing Institution)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in6.1\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in6.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">sIRB (Reviewing Institution) Name</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" id=\"item.in6.1_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in6.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Name of the sIRB (Reviewing Institution)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in6.10\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in6.10</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Department Name or Division</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" id=\"item.in6.10_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in6.10_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">The department name or division of the sIRB, if applicable</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in6.3\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in6.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Institution Street Address</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" id=\"item.in6.3_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in6.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Physical address of the sIRB (Reviewing Institution)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" id=\"item.in6.4\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in6.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Institution City</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" id=\"item.in6.5\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in6.5</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Institution State</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" id=\"item.in6.6\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in6.6</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Institution Zip Code</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" id=\"item.in6.7\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in6.7</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Institution Country</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Initial Value: string = United States</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in6.8\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> in6.8</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is a Federal Wide Assurance (FWA) Number assigned?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.in6.8\">4 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" id=\"item.in6.8_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in6.8_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance.  If the user believes that there is a FWA number assigned but needs to confirm this, select &quot;temporarily unavailable&quot;. If the user does not know if there is a FWA number assigned, select &quot;No Information&quot;.</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in6.9\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-integer.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Integer\" class=\"hierarchy\"/> in6.9</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Federal Wide Assurance Number (if assigned)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-integer\">integer</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: <span><a href=\"#item.in6.8\">in6.8</a> = Yes (expandedYes-NoIndicator#Y)</span></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)\" id=\"item.in6.9_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in6.9_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If assigned, enter just numeric value of FWA.</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)\" id=\"item.in6.11\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> in6.11</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is the sIRB a 3rd party institution?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.in6.11\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)\" id=\"item.in6.11_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in6.11_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is the sIRB an external 3rd party institution, outside of the lead Principal Investigator institution?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" id=\"item.DIVIDER3\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> DIVIDER3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">null</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" id=\"item.in7\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> in7</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Lead Principal Investigator</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in7.1\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> in7.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Lead Principal Investigator Institution</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in7.1.1\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.1.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Lead Principal Investigator Institution Name</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in7.1.1_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in7.1.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Name of institution for the lead principal investigator</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in7.1.10\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.1.10</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Department Name or Division</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in7.1.10_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in7.1.10_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">The department name or division of the lead principal investigator</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in7.1.3\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.1.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Institution Phone</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in7.1.3_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in7.1.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">10-digit phone number, including area code, for the institution of the lead principal investigator</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in7.1.4\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> in7.1.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is a Federal Wide Assurance (FWA) Number assigned?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.in7.1.4\">4 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in7.1.4_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in7.1.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance.  If the user believes that there is a FWA number assigned but needs to confirm this, select &quot;temporarily unavailable&quot;. If the user does not know if there is a FWA number assigned, select &quot;No Information&quot;.</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)\" id=\"item.in7.1.5\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-integer.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Integer\" class=\"hierarchy\"/> in7.1.5</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Federal Wide Assurance Number (if assigned)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-integer\">integer</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: <span><a href=\"#item.in7.1.4\">in7.1.4</a> = Yes (expandedYes-NoIndicator#Y)</span></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)\" id=\"item.in7.1.5_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in7.1.5_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">If assigned, enter just numeric value of FWA.</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in7.3\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> in7.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Lead Principal Investigator</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in7.3.1\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.3.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Lead Principal Investigator First Name</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in7.3.1_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in7.3.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">First Name or Given Name of the lead PI responsible for the overall study</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in7.3.2\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.3.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Lead Principal Investigator Last Name</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in7.3.2_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in7.3.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Last name, surname or family name of the lead PI responsible for the overall study</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in7.3.3\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.3.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Lead Principal Investigator Suffix</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in7.3.3_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in7.3.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in7.3.4\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.3.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Academic and Professional Degrees associated with the Lead Principal Investigator</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in7.3.4_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in7.3.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Academic and Professional degrees associated with the lead principal investigator</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in7.3.10\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.3.10</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Department Name or Division</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in7.3.10_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in7.3.10_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">The department name or division of the lead PI</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in7.3.5\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.3.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Phone</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in7.3.5_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in7.3.5_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">10-digit phone number, including area code, for the lead principal investigator</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in7.3.6\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.3.6</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Email address</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in7.3.6_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in7.3.6_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Email address associated with the lead principal investigator</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)\" id=\"item.in7.3.7\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> in7.3.7</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Address of Lead Principal Investigator</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11011.png)\" id=\"item.in7.3.7.1\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.3.7.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Street Address</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110100.png)\" id=\"item.in7.3.7.1_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in7.3.7.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Physical address</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)\" id=\"item.in7.3.7.2\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.3.7.2</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">City</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)\" id=\"item.in7.3.7.3\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.3.7.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">State</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)\" id=\"item.in7.3.7.4\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.3.7.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Zip Code</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)\" id=\"item.in7.3.7.5\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.3.7.5</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Country</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Initial Value: string = United States</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" id=\"item.in7.9\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.9</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Lead Principal Investigator Unique Site (read-only)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/questionnaire-definitions.html#Questionnaire.item.readOnly\" title=\"Is Readonly\"><img src=\"icon-qi-readonly.png\" alt=\"icon\"/></a><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\" alt=\"icon\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Expressions: <ul><li style=\"font-size: 11px\"><a href=\"http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression\">Calculated Value</a>: <code>%combinedLeadPIUniqueSite</code></li></ul></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)\" id=\"item.in7.10\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in7.10</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Lead Principal Investigator Full Name, Suffix and Degrees</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/questionnaire-definitions.html#Questionnaire.item.readOnly\" title=\"Is Readonly\"><img src=\"icon-qi-readonly.png\" alt=\"icon\"/></a><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\" alt=\"icon\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Expressions: <ul><li style=\"font-size: 11px\"><a href=\"http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression\">Calculated Value</a>: <code>%fullNameDSLeadPI</code></li></ul></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" id=\"item.DIVIDER4\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> DIVIDER4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">null</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" id=\"item.in8\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> in8</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Relying Site(s)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in8.5\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> in8.5</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in8.5.1\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> in8.5.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is this relying site at the same institution as where the lead principal investigator is conducting the study?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.in8.5.1\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in8.5.1_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in8.5.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">This question is optional. It can be used to pre-populate the lead principal investigator institution details if this relying site is at the same institution as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in8.5.2\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> in8.5.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is this relying site at the same site as where the lead principal investigator is conducting the study?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: <span><a href=\"#item.in8.5.1\">in8.5.1</a> = Yes (expandedYes-NoIndicator#Y)</span><br/>Options: <a href=\"#opt-item.in8.5.2\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in8.5.2_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in8.5.2_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">This question is optional. It can be used to pre-populate the lead principal investigator site details if this relying site is at the same site as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in8.5.3\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> in8.5.3</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.in8.5.3\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in8.5.3_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in8.5.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">This question is optional. It can be used to pre-populate the lead principal investigator details if this relying site PI is the same PI as the lead principal investigator conducting the study. If you do not want pre-population to occur, you may leave this question blank.</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)\" id=\"item.in8.5.4\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> in8.5.4</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is this relying site also considered to be the lead site for the study?</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.in8.5.4\">2 options</a></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)\" id=\"item.in8.5.4_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in8.5.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Indicator that the lead PI site where the study is being conducted is also participating as this relying site</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)\" id=\"item.in8.1\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> in8.1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Relying Site Institution</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in8.1.1\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in8.1.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Relying Institution Name</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Expressions: <ul><li style=\"font-size: 11px\"><a href=\"http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression\">Calculated Value</a>: <code>iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.1').answer.value)</code></li></ul></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in8.1.1_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in8.1.1_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Name of Institution for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions.</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in8.1.10\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in8.1.10</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Department Name or Division</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Expressions: <ul><li style=\"font-size: 11px\"><a href=\"http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression\">Calculated Value</a>: <code>iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.10').answer.value)</code></li></ul></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in8.1.10_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in8.1.10_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">The department name or division for the relying site</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in8.1.3\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in8.1.3</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Relying Institution Phone</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Expressions: <ul><li style=\"font-size: 11px\"><a href=\"http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression\">Calculated Value</a>: <code>iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.3').answer.value)</code></li></ul></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in8.1.3_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in8.1.3_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">10-digit phone number, including area code, for the relying institution</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in8.1.4\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-coding.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Coding\" class=\"hierarchy\"/> in8.1.4</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Is a Federal Wide Assurance (FWA) Number assigned?</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice\">choice</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Options: <a href=\"#opt-item.in8.1.4\">4 options</a><br/>Expressions: <ul><li style=\"font-size: 11px\"><a href=\"http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression\">Calculated Value</a>: <code>iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.4').answer.valueCoding)</code></li></ul></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)\" id=\"item.in8.1.4_help\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> in8.1.4_help</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance.  If the user believes that there is a FWA number assigned but needs to confirm this, select &quot;temporarily unavailable&quot;. If the user does not know if there is a FWA number assigned, select &quot;No Information&quot;.</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)\" id=\"item.in8.1.5\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-integer.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Integer\" class=\"hierarchy\"/> in8.1.5</td><td style=\"vertical-and-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Enable When: <span><a href=\"#item.in9.2\">in9.2</a> = Yes (expandedYes-NoIndicator#Y)</span></td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" id=\"item.DIVIDER6\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> DIVIDER6</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">null</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)\" id=\"item.in10\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> in10</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Questionnaire Version Details</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)\" id=\"item.in10.1\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> in10.1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Questionnaire Version</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/questionnaire-definitions.html#Questionnaire.item.readOnly\" title=\"Is Readonly\"><img src=\"icon-qi-readonly.png\" alt=\"icon\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Initial Value: string = 2</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)\" id=\"item.in10.2\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vline.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-date.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Date\" class=\"hierarchy\"/> in10.2</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Questionnaire Version Date</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date\">date</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/questionnaire-definitions.html#Questionnaire.item.readOnly\" title=\"Is Readonly\"><img src=\"icon-qi-readonly.png\" alt=\"icon\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Initial Value: date = 2021-10-18</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)\" id=\"item.DIVIDER7\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-display.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Display\" class=\"hierarchy\"/> DIVIDER7</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">null</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display\">display</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.png)\" id=\"item.ADMIN00\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-group.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Group\" class=\"hierarchy\"/> ADMIN00</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Administrative Use Only  (will be hidden in the future)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group\">group</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\" alt=\"icon\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" id=\"item.ADMIN01\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> ADMIN01</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Link ID prefix</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\" alt=\"icon\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Initial Value: string = in</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" id=\"item.ADMIN02\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> ADMIN02</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\" alt=\"icon\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Initial Value: string = temporarily unavailable</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)\" id=\"item.ADMIN03\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> ADMIN03</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">ID of the Research Study FHIR Resource associated with the study Questionnaire Responses</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\" alt=\"icon\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Initial Value: string = temporarily unavailable</td></tr>\r\n<tr style=\"border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck000.png)\" id=\"item.ADMIN04\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon-q-string.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"String\" class=\"hierarchy\"/> ADMIN04</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Questionnaire Response ID of the local considerations Questionnaire Response, if any</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string\">string</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"http://hl7.org/fhir/R4/extension-questionnaire-hidden.html\" title=\"Is a hidden item\"><img src=\"icon-qi-hidden.png\" alt=\"icon\"/></a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/></tr>\r\n<tr><td colspan=\"6\" class=\"hierarchy\"><br/><a href=\"http://hl7.org/fhir/R4/formats.html#table\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table><hr/><p><b>Option Sets</b></p><a name=\"opt-item.in1.4\"> </a><p><b>Answer options for in1.4</b></p><ul><li style=\"font-size: 11px\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#INT (&quot;Interventional&quot;)</li><li style=\"font-size: 11px\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#OBS (&quot;Observational&quot;)</li></ul><a name=\"opt-item.in5.1\"> </a><p><b>Answer options for in5.1</b></p><ul><li style=\"font-size: 11px\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#SFS (&quot;Sponsor or Funding Source&quot;)</li><li style=\"font-size: 11px\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#CRO (&quot;Contract Research Organization (CRO)&quot;)</li></ul><a name=\"opt-item.in6.8\"> </a><p><b>Answer options for in6.8</b></p><ul><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#NI (&quot;No Information&quot;)</li><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#NAV (&quot;temporarily unavailable&quot;)</li></ul><a name=\"opt-item.in6.11\"> </a><p><b>Answer options for in6.11</b></p><ul><li style=\"font-size: 11px\"><img src=\"icon-not-selected.png\" alt=\"icon\"/>http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><img src=\"icon-selected.png\" alt=\"icon\"/>http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name=\"opt-item.in7.1.4\"> </a><p><b>Answer options for in7.1.4</b></p><ul><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#NI (&quot;No Information&quot;)</li><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#NAV (&quot;temporarily unavailable&quot;)</li></ul><a name=\"opt-item.in8.5.1\"> </a><p><b>Answer options for in8.5.1</b></p><ul><li style=\"font-size: 11px\"><img src=\"icon-not-selected.png\" alt=\"icon\"/>http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><img src=\"icon-selected.png\" alt=\"icon\"/>http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name=\"opt-item.in8.5.2\"> </a><p><b>Answer options for in8.5.2</b></p><ul><li style=\"font-size: 11px\"><img src=\"icon-not-selected.png\" alt=\"icon\"/>http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><img src=\"icon-selected.png\" alt=\"icon\"/>http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name=\"opt-item.in8.5.3\"> </a><p><b>Answer options for in8.5.3</b></p><ul><li style=\"font-size: 11px\"><img src=\"icon-not-selected.png\" alt=\"icon\"/>http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><img src=\"icon-selected.png\" alt=\"icon\"/>http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name=\"opt-item.in8.5.4\"> </a><p><b>Answer options for in8.5.4</b></p><ul><li style=\"font-size: 11px\"><img src=\"icon-not-selected.png\" alt=\"icon\"/>http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\"><img src=\"icon-selected.png\" alt=\"icon\"/>http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name=\"opt-item.in8.1.4\"> </a><p><b>Answer options for in8.1.4</b></p><ul><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#NI (&quot;No Information&quot;)</li><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#NAV (&quot;temporarily unavailable&quot;)</li></ul><a name=\"opt-item.in8.1.6\"> </a><p><b>Answer options for in8.1.6</b></p><ul><li style=\"font-size: 11px\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#APPROVED (&quot;Approved for reliance&quot;)</li><li style=\"font-size: 11px\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DENIED (&quot;Denied reliance&quot;)</li><li style=\"font-size: 11px\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#POSSIBLE (&quot;Potential/possible&quot;)</li><li style=\"font-size: 11px\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#CANCELLED (&quot;Cancelled or not participating&quot;)</li><li style=\"font-size: 11px\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#ONHOLD (&quot;Temporarily on hold&quot;)</li></ul><a name=\"opt-item.in9.1\"> </a><p><b>Answer options for in9.1</b></p><ul><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name=\"opt-item.in9.2\"> </a><p><b>Answer options for in9.2</b></p><ul><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style=\"font-size: 11px\">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name=\"opt-item.in9.4\"> </a><p><b>Answer options for in9.4</b></p><ul><li style=\"font-size: 11px\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IND (&quot;IND&quot;)</li><li style=\"font-size: 11px\">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IDE (&quot;IDE&quot;)</li></ul></div>"
  },
  "url" : "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate",
  "version" : "1.0.0",
  "name" : "SIRBInitiateAStudyQuestionnaire",
  "title" : "Initiate a Study Questionnaire",
  "status" : "draft",
  "subjectType" : [
    "ResearchStudy"
  ],
  "date" : "2023-04-24T20:03:27+00:00",
  "publisher" : "HL7 International - BR&R Work Group",
  "contact" : [
    {
      "name" : "HL7 International - Biomedical Research and Regulation",
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://www.hl7.org/Special/committees/rcrim"
        }
      ]
    }
  ],
  "description" : "Initiate a Study Questionnaire",
  "jurisdiction" : [
    {
      "coding" : [
        {
          "system" : "urn:iso:std:iso:3166",
          "code" : "US",
          "display" : "United States of America"
        }
      ],
      "text" : "United States of America"
    }
  ],
  "item" : [
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/questionnaire-item-control",
                "code" : "gtable",
                "display" : "Group Table"
              }
            ],
            "text" : "Group Table"
          }
        }
      ],
      "linkId" : "in1",
      "text" : "Research Study Details",
      "_text" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString" : "color:#274e90; font-size: 160%"
          }
        ]
      },
      "type" : "group",
      "required" : false,
      "repeats" : false,
      "item" : [
        {
          "linkId" : "in1.1",
          "text" : "Study Title",
          "type" : "string",
          "required" : true,
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in1.1_help",
              "text" : "The official title of a protocol used to identify a clinical study.Include phase (e.g. pilot proof of concept study, phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc.), if the study is multi-center, the investigational agent (drug, device, biologic, vaccine, procedural and/or behavioral etc., and target disease(s)",
              "type" : "display"
            }
          ]
        },
        {
          "linkId" : "in1.2",
          "text" : "Study Title (Short)",
          "type" : "string",
          "required" : true,
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in1.2_help",
              "text" : "A short study title written in language intended for the lay public.",
              "type" : "display"
            }
          ]
        },
        {
          "linkId" : "in1.3",
          "text" : "IRB Protocol Number",
          "type" : "string",
          "required" : true,
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in1.3_help",
              "text" : "The Protocol Number assigned by the sIRB",
              "type" : "display"
            }
          ]
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept" : {
                "coding" : [
                  {
                    "system" : "http://hl7.org/fhir/questionnaire-item-control",
                    "code" : "drop-down",
                    "display" : "Drop down"
                  }
                ],
                "text" : "Drop down"
              }
            }
          ],
          "linkId" : "in1.4",
          "text" : "Study Type",
          "type" : "choice",
          "required" : true,
          "answerOption" : [
            {
              "valueCoding" : {
                "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code" : "INT",
                "display" : "Interventional"
              }
            },
            {
              "valueCoding" : {
                "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code" : "OBS",
                "display" : "Observational"
              }
            }
          ],
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in1.4_help",
              "text" : "Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)",
              "type" : "display"
            }
          ]
        }
      ]
    },
    {
      "linkId" : "DIVIDER1",
      "type" : "display"
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/questionnaire-item-control",
                "code" : "gtable",
                "display" : "Group Table"
              }
            ],
            "text" : "Group Table"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "Other Org Relationship Type",
            "name" : "otherOrgRelTypeOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "iif(item.where(linkId = 'in5.1').answer.valueCoding.display.exists(), item.where(linkId = 'in5.1').answer.valueCoding.display,  ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "Other Org Name",
            "name" : "otherOrgNameOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "iif(item.where(linkId = 'in5.2').answer.valueString.exists(), item.where(linkId = 'in5.2').answer.valueString,  ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "Other Org Phone",
            "name" : "otherOrgPhoneOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "iif(item.where(linkId = 'in5.3').answer.valueString.exists(), item.where(linkId = 'in5.3').answer.valueString,  ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "Other Org Protocol",
            "name" : "otherOrgProtocolOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "iif(item.where(linkId = 'in5.4').answer.valueString.exists(), item.where(linkId = 'in5.4').answer.valueString, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "combination of Other Org fields to make unique identifier",
            "name" : "combinedOtherOrgUniqueOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "%otherOrgNameOneRepetition   +   '  |  '  +  %otherOrgPhoneOneRepetition  +    '  |  '  + %otherOrgProtocolOneRepetition +   '  |  '    +  %otherOrgRelTypeOneRepetition"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "Funding Source/Sponsor Protocol and Funding Source/Sponsor Name",
            "name" : "otherOrgProtocolWithNameOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "%otherOrgProtocolOneRepetition +   '  ('    + %otherOrgNameOneRepetition  +  ')'"
          }
        }
      ],
      "linkId" : "in5",
      "text" : "Other Organization(s) Involved",
      "_text" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString" : "color:#274e90; font-size: 160%"
          }
        ]
      },
      "type" : "group",
      "required" : false,
      "repeats" : true,
      "item" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept" : {
                "coding" : [
                  {
                    "system" : "http://hl7.org/fhir/questionnaire-item-control",
                    "code" : "drop-down",
                    "display" : "Drop down"
                  }
                ],
                "text" : "Drop down"
              }
            }
          ],
          "linkId" : "in5.1",
          "text" : "Relationship Type",
          "type" : "choice",
          "required" : true,
          "answerOption" : [
            {
              "valueCoding" : {
                "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code" : "SFS",
                "display" : "Sponsor or Funding Source"
              }
            },
            {
              "valueCoding" : {
                "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code" : "CRO",
                "display" : "Contract Research Organization (CRO)"
              }
            }
          ],
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in5.1_help",
              "text" : "Select the organization's type of involvement in the study",
              "type" : "display"
            }
          ]
        },
        {
          "linkId" : "in5.2",
          "text" : "Organization Name",
          "type" : "string",
          "required" : true,
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in5.2_help",
              "text" : "e.g. NIH or company name",
              "type" : "display"
            }
          ]
        },
        {
          "linkId" : "in5.3",
          "text" : "Phone",
          "type" : "string",
          "required" : false,
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in5.3_help",
              "text" : "10 digit phone number, including area code",
              "type" : "display"
            }
          ]
        },
        {
          "linkId" : "in5.4",
          "text" : "Sponsor or Funding Source Protocol Number, if applicable",
          "type" : "string",
          "required" : false,
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in5.4_help",
              "text" : "Unique Protocol Identification Number used by the sponsor, if applicable",
              "type" : "display"
            }
          ]
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean" : true
            },
            {
              "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
              "valueExpression" : {
                "language" : "text/fhirpath",
                "expression" : "%combinedOtherOrgUniqueOneRepetition"
              }
            }
          ],
          "linkId" : "in5.5",
          "text" : "Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)",
          "type" : "string",
          "required" : false,
          "readOnly" : true
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean" : true
            },
            {
              "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
              "valueExpression" : {
                "language" : "text/fhirpath",
                "expression" : "%otherOrgProtocolWithNameOneRepetition"
              }
            }
          ],
          "linkId" : "in5.6",
          "text" : "Protocol Number with Organization Name (read-only)",
          "type" : "string",
          "required" : false,
          "readOnly" : true
        }
      ]
    },
    {
      "linkId" : "DIVIDER2",
      "type" : "display"
    },
    {
      "linkId" : "in6",
      "text" : "sIRB (Reviewing Institution)",
      "_text" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString" : "color:#274e90; font-size: 160%"
          }
        ]
      },
      "type" : "group",
      "item" : [
        {
          "linkId" : "in6.1",
          "text" : "sIRB (Reviewing Institution) Name",
          "type" : "string",
          "required" : true,
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in6.1_help",
              "text" : "Name of the sIRB (Reviewing Institution)",
              "type" : "display"
            }
          ]
        },
        {
          "linkId" : "in6.10",
          "text" : "Department Name or Division",
          "type" : "string",
          "required" : false,
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in6.10_help",
              "text" : "The department name or division of the sIRB, if applicable",
              "type" : "display"
            }
          ]
        },
        {
          "linkId" : "in6.3",
          "text" : "Institution Street Address",
          "type" : "string",
          "required" : true,
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in6.3_help",
              "text" : "Physical address of the sIRB (Reviewing Institution)",
              "type" : "display"
            }
          ]
        },
        {
          "linkId" : "in6.4",
          "text" : "Institution City",
          "type" : "string",
          "required" : true
        },
        {
          "linkId" : "in6.5",
          "text" : "Institution State",
          "type" : "string",
          "required" : true
        },
        {
          "linkId" : "in6.6",
          "text" : "Institution Zip Code",
          "type" : "string",
          "required" : true
        },
        {
          "linkId" : "in6.7",
          "text" : "Institution Country",
          "type" : "string",
          "required" : false,
          "initial" : [
            {
              "valueString" : "United States"
            }
          ]
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept" : {
                "coding" : [
                  {
                    "system" : "http://hl7.org/fhir/questionnaire-item-control",
                    "code" : "drop-down",
                    "display" : "Drop down"
                  }
                ],
                "text" : "Drop down"
              }
            }
          ],
          "linkId" : "in6.8",
          "text" : "Is a Federal Wide Assurance (FWA) Number assigned?",
          "type" : "choice",
          "required" : true,
          "answerOption" : [
            {
              "valueCoding" : {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code" : "Y",
                "display" : "Yes"
              }
            },
            {
              "valueCoding" : {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code" : "N",
                "display" : "No"
              }
            },
            {
              "valueCoding" : {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code" : "NI",
                "display" : "No Information"
              }
            },
            {
              "valueCoding" : {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code" : "NAV",
                "display" : "temporarily unavailable"
              }
            }
          ],
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in6.8_help",
              "text" : "DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance.  If the user believes that there is a FWA number assigned but needs to confirm this, select \"temporarily unavailable\". If the user does not know if there is a FWA number assigned, select \"No Information\".",
              "type" : "display"
            }
          ]
        },
        {
          "linkId" : "in6.9",
          "text" : "Federal Wide Assurance Number (if assigned)",
          "type" : "integer",
          "enableWhen" : [
            {
              "question" : "in6.8",
              "operator" : "=",
              "answerCoding" : {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code" : "Y"
              }
            }
          ],
          "required" : false,
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in6.9_help",
              "text" : "If assigned, enter just numeric value of FWA.",
              "type" : "display"
            }
          ]
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept" : {
                "coding" : [
                  {
                    "system" : "http://hl7.org/fhir/questionnaire-item-control",
                    "code" : "drop-down",
                    "display" : "Drop down"
                  }
                ],
                "text" : "Drop down"
              }
            }
          ],
          "linkId" : "in6.11",
          "text" : "Is the sIRB a 3rd party institution?",
          "type" : "choice",
          "required" : false,
          "answerOption" : [
            {
              "valueCoding" : {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code" : "Y",
                "display" : "Yes"
              }
            },
            {
              "valueCoding" : {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code" : "N",
                "display" : "No"
              },
              "initialSelected" : true
            }
          ],
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in6.11_help",
              "text" : "Is the sIRB an external 3rd party institution, outside of the lead Principal Investigator institution?",
              "type" : "display"
            }
          ]
        }
      ]
    },
    {
      "linkId" : "DIVIDER3",
      "type" : "display"
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "institution for the lead PI",
            "name" : "leadPIInstitutionName",
            "language" : "text/fhirpath",
            "expression" : "iif(%resource.descendants().where(linkId = 'in7.1.1').answer.value.exists(), %resource.descendants().where(linkId = 'in7.1.1').answer.value, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "dept for the lead PI",
            "name" : "leadPIDept",
            "language" : "text/fhirpath",
            "expression" : "iif(%resource.descendants().where(linkId = 'in7.1.10').answer.value.exists(), %resource.descendants().where(linkId = 'in7.1.10').answer.value, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "first name of the lead PI",
            "name" : "leadPIFirstName",
            "language" : "text/fhirpath",
            "expression" : "iif(%resource.descendants().where(linkId = 'in7.3.1').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.1').answer.value, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "last name of the lead PI",
            "name" : "leadPILastName",
            "language" : "text/fhirpath",
            "expression" : "iif(%resource.descendants().where(linkId = 'in7.3.2').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.2').answer.value, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "suffix of the lead PI",
            "name" : "leadPISuffix",
            "language" : "text/fhirpath",
            "expression" : "iif(%resource.descendants().where(linkId = 'in7.3.3').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.3').answer.value, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "degrees of the lead PI",
            "name" : "leadPIDegrees",
            "language" : "text/fhirpath",
            "expression" : "iif(%resource.descendants().where(linkId = 'in7.3.4').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.4').answer.value, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "city of the lead PI",
            "name" : "leadPICity",
            "language" : "text/fhirpath",
            "expression" : "iif(%resource.descendants().where(linkId = 'in7.3.7.2').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.7.2').answer.value, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "state of the lead PI",
            "name" : "leadPIState",
            "language" : "text/fhirpath",
            "expression" : "iif(%resource.descendants().where(linkId = 'in7.3.7.3').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.7.3').answer.value, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "full name, suffix and degrees for the lead PI",
            "name" : "fullNameDSLeadPI",
            "language" : "text/fhirpath",
            "expression" : "%leadPIFirstName + ' ' + %leadPILastName + ', ' + iif(%leadPISuffix = ' ', '', %leadPISuffix+ ', ') + %leadPIDegrees"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "city and state of the lead PI",
            "name" : "leadPILocation",
            "language" : "text/fhirpath",
            "expression" : "iif(%resource.descendants().where(linkId = 'in7.3.7.2').answer.value.exists(), %leadPICity, ' ') + ', ' + iif(%resource.descendants().where(linkId = 'in7.3.7.3').answer.value.exists(), %leadPIState, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "full name, suffix and degrees for the lead PI with the lead PI institution and lead PI dept",
            "name" : "combinedLeadPIUniqueSite",
            "language" : "text/fhirpath",
            "expression" : "%leadPIInstitutionName + '  |  '  + %leadPIDept + '  |  ' + %fullNameDSLeadPI + '  |  ' + %leadPILocation"
          }
        }
      ],
      "linkId" : "in7",
      "text" : "Lead Principal Investigator",
      "_text" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString" : "color: #274e90; font-size: 160%"
          }
        ]
      },
      "type" : "group",
      "required" : false,
      "repeats" : false,
      "item" : [
        {
          "linkId" : "in7.1",
          "text" : "Lead Principal Investigator Institution",
          "_text" : {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/rendering-style",
                "valueString" : "color:#2a623d;  font-size: 130%"
              }
            ]
          },
          "type" : "group",
          "required" : false,
          "item" : [
            {
              "linkId" : "in7.1.1",
              "text" : "Lead Principal Investigator Institution Name",
              "type" : "string",
              "required" : true,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in7.1.1_help",
                  "text" : "Name of institution for the lead principal investigator",
                  "type" : "display"
                }
              ]
            },
            {
              "linkId" : "in7.1.10",
              "text" : "Department Name or Division",
              "type" : "string",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in7.1.10_help",
                  "text" : "The department name or division of the lead principal investigator",
                  "type" : "display"
                }
              ]
            },
            {
              "linkId" : "in7.1.3",
              "text" : "Institution Phone",
              "type" : "string",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in7.1.3_help",
                  "text" : "10-digit phone number, including area code, for the institution of the lead principal investigator",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "drop-down",
                        "display" : "Drop down"
                      }
                    ],
                    "text" : "Drop down"
                  }
                }
              ],
              "linkId" : "in7.1.4",
              "text" : "Is a Federal Wide Assurance (FWA) Number assigned?",
              "type" : "choice",
              "required" : true,
              "answerOption" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "Y",
                    "display" : "Yes"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "N",
                    "display" : "No"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "NI",
                    "display" : "No Information"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "NAV",
                    "display" : "temporarily unavailable"
                  }
                }
              ],
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in7.1.4_help",
                  "text" : "DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance.  If the user believes that there is a FWA number assigned but needs to confirm this, select \"temporarily unavailable\". If the user does not know if there is a FWA number assigned, select \"No Information\".",
                  "type" : "display"
                }
              ]
            },
            {
              "linkId" : "in7.1.5",
              "text" : "Federal Wide Assurance Number (if assigned)",
              "type" : "integer",
              "enableWhen" : [
                {
                  "question" : "in7.1.4",
                  "operator" : "=",
                  "answerCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "Y"
                  }
                }
              ],
              "enableBehavior" : "all",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in7.1.5_help",
                  "text" : "If assigned, enter just numeric value of FWA.",
                  "type" : "display"
                }
              ]
            }
          ]
        },
        {
          "linkId" : "in7.3",
          "text" : "Lead Principal Investigator",
          "_text" : {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/rendering-style",
                "valueString" : "color:#2a623d; font-size: 130%"
              }
            ]
          },
          "type" : "group",
          "required" : false,
          "item" : [
            {
              "linkId" : "in7.3.1",
              "text" : "Lead Principal Investigator First Name",
              "type" : "string",
              "required" : true,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in7.3.1_help",
                  "text" : "First Name or Given Name of the lead PI responsible for the overall study",
                  "type" : "display"
                }
              ]
            },
            {
              "linkId" : "in7.3.2",
              "text" : "Lead Principal Investigator Last Name",
              "type" : "string",
              "required" : true,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in7.3.2_help",
                  "text" : "Last name, surname or family name of the lead PI responsible for the overall study",
                  "type" : "display"
                }
              ]
            },
            {
              "linkId" : "in7.3.3",
              "text" : "Lead Principal Investigator Suffix",
              "type" : "string",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in7.3.3_help",
                  "text" : "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.",
                  "type" : "display"
                }
              ]
            },
            {
              "linkId" : "in7.3.4",
              "text" : "Academic and Professional Degrees associated with the Lead Principal Investigator",
              "type" : "string",
              "required" : true,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in7.3.4_help",
                  "text" : "Academic and Professional degrees associated with the lead principal investigator",
                  "type" : "display"
                }
              ]
            },
            {
              "linkId" : "in7.3.10",
              "text" : "Department Name or Division",
              "type" : "string",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in7.3.10_help",
                  "text" : "The department name or division of the lead PI",
                  "type" : "display"
                }
              ]
            },
            {
              "linkId" : "in7.3.5",
              "text" : "Phone",
              "type" : "string",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in7.3.5_help",
                  "text" : "10-digit phone number, including area code, for the lead principal investigator",
                  "type" : "display"
                }
              ]
            },
            {
              "linkId" : "in7.3.6",
              "text" : "Email address",
              "type" : "string",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in7.3.6_help",
                  "text" : "Email address associated with the lead principal investigator",
                  "type" : "display"
                }
              ]
            },
            {
              "linkId" : "in7.3.7",
              "text" : "Address of Lead Principal Investigator",
              "type" : "group",
              "required" : false,
              "item" : [
                {
                  "linkId" : "in7.3.7.1",
                  "text" : "Street Address",
                  "type" : "string",
                  "required" : false,
                  "item" : [
                    {
                      "extension" : [
                        {
                          "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                          "valueCodeableConcept" : {
                            "coding" : [
                              {
                                "system" : "http://hl7.org/fhir/questionnaire-item-control",
                                "code" : "help",
                                "display" : "Help-Button"
                              }
                            ],
                            "text" : "Help-Button"
                          }
                        }
                      ],
                      "linkId" : "in7.3.7.1_help",
                      "text" : "Physical address",
                      "type" : "display"
                    }
                  ]
                },
                {
                  "linkId" : "in7.3.7.2",
                  "text" : "City",
                  "type" : "string",
                  "required" : true
                },
                {
                  "linkId" : "in7.3.7.3",
                  "text" : "State",
                  "type" : "string",
                  "required" : true
                },
                {
                  "linkId" : "in7.3.7.4",
                  "text" : "Zip Code",
                  "type" : "string",
                  "required" : false
                },
                {
                  "linkId" : "in7.3.7.5",
                  "text" : "Country",
                  "type" : "string",
                  "required" : false,
                  "initial" : [
                    {
                      "valueString" : "United States"
                    }
                  ]
                }
              ]
            }
          ]
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean" : true
            },
            {
              "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
              "valueExpression" : {
                "language" : "text/fhirpath",
                "expression" : "%combinedLeadPIUniqueSite"
              }
            }
          ],
          "linkId" : "in7.9",
          "text" : "Lead Principal Investigator Unique Site (read-only)",
          "type" : "string",
          "required" : false,
          "readOnly" : true
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean" : true
            },
            {
              "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
              "valueExpression" : {
                "language" : "text/fhirpath",
                "expression" : "%fullNameDSLeadPI"
              }
            }
          ],
          "linkId" : "in7.10",
          "text" : "Lead Principal Investigator Full Name, Suffix and Degrees",
          "type" : "string",
          "required" : false,
          "readOnly" : true
        }
      ]
    },
    {
      "linkId" : "DIVIDER4",
      "type" : "display"
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "is this relying site at the lead PI institution",
            "name" : "isSameInstitutionOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "item.descendants().where(linkId = 'in8.5.1').answer.valueCoding.code"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "is this relying site the same as the lead PI site",
            "name" : "isSameSiteOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "item.descendants().where(linkId = 'in8.5.2').answer.valueCoding.code"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "is this relying site PI the same as the lead PI",
            "name" : "isSamePIOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "item.descendants().where(linkId = 'in8.5.3').answer.valueCoding.code"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "is the site functioning as a lead site",
            "name" : "isFunctioningAsLeadOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "item.descendants().where(linkId='in8.5.4').answer.valueCoding.code"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "institution for this relying site PI",
            "name" : "sitePIInstitutionNameOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "iif(item.descendants().where(linkId = 'in8.1.1').answer.valueString.exists(), item.descendants().where(linkId = 'in8.1.1').answer.valueString, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "dept for this relying site PI",
            "name" : "sitePIDeptOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "iif(item.descendants().where(linkId = 'in8.1.10').answer.valueString.exists(), item.descendants().where(linkId = 'in8.1.10').answer.valueString, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "first name of this relying site PI",
            "name" : "sitePIFirstNameOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "iif(item.descendants().where(linkId = 'in8.3.1').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.1').answer.valueString, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "last name of this relying site PI",
            "name" : "sitePILastNameOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "iif(item.descendants().where(linkId = 'in8.3.2').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.2').answer.valueString, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "suffix of this relying site PI",
            "name" : "sitePISuffixOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "iif(item.descendants().where(linkId = 'in8.3.3').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.3').answer.valueString, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "degrees of this relying site PI",
            "name" : "sitePIDegreesOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "iif(item.descendants().where(linkId = 'in8.3.4').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.4').answer.valueString, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "city of the relying site PI",
            "name" : "sitePICityOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "iif(item.descendants().where(linkId = 'in8.3.7.2').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.7.2').answer.valueString, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "state of the relying site PI",
            "name" : "sitePIStateOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "iif(item.descendants().where(linkId = 'in8.3.7.3').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.7.3').answer.valueString, ' ')"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "full name, suffix and degrees for this relying site PI",
            "name" : "fullNameDSSitePIOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "%sitePIFirstNameOneRepetition + ' '  + %sitePILastNameOneRepetition + ', '  + iif(%sitePISuffixOneRepetition = ' ',  '', %sitePISuffixOneRepetition  + ', ') +  %sitePIDegreesOneRepetition"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "city and state of the relying site PI",
            "name" : "sitePILocationOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "%sitePICityOneRepetition + ', ' + %sitePIStateOneRepetition"
          }
        },
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/variable",
          "valueExpression" : {
            "description" : "full name, suffix and degrees for this relying site PI and the relying site PI institution and dept",
            "name" : "combinedSitePIUniqueSiteOneRepetition",
            "language" : "text/fhirpath",
            "expression" : "%sitePIInstitutionNameOneRepetition + '  |  '  + %sitePIDeptOneRepetition + '  |  ' + %fullNameDSSitePIOneRepetition + '  |  ' + %sitePILocationOneRepetition"
          }
        }
      ],
      "linkId" : "in8",
      "text" : "Relying Site(s)",
      "_text" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString" : "color: #274e90; font-size: 160%"
          }
        ]
      },
      "type" : "group",
      "required" : false,
      "repeats" : true,
      "item" : [
        {
          "linkId" : "in8.5",
          "text" : "Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator",
          "_text" : {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/rendering-style",
                "valueString" : "color:#2a623d;  font-size: 130%"
              }
            ]
          },
          "type" : "group",
          "required" : false,
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "drop-down",
                        "display" : "Drop down"
                      }
                    ],
                    "text" : "Drop down"
                  }
                }
              ],
              "linkId" : "in8.5.1",
              "text" : "Is this relying site at the same institution as where the lead principal investigator is conducting the study?",
              "type" : "choice",
              "required" : false,
              "answerOption" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "Y",
                    "display" : "Yes"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "N",
                    "display" : "No"
                  },
                  "initialSelected" : true
                }
              ],
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.5.1_help",
                  "text" : "This question is optional. It can be used to pre-populate the lead principal investigator institution details if this relying site is at the same institution as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "drop-down",
                        "display" : "Drop down"
                      }
                    ],
                    "text" : "Drop down"
                  }
                }
              ],
              "linkId" : "in8.5.2",
              "text" : "Is this relying site at the same site as where the lead principal investigator is conducting the study?",
              "type" : "choice",
              "enableWhen" : [
                {
                  "question" : "in8.5.1",
                  "operator" : "=",
                  "answerCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "Y"
                  }
                }
              ],
              "required" : false,
              "answerOption" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "Y",
                    "display" : "Yes"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "N",
                    "display" : "No"
                  },
                  "initialSelected" : true
                }
              ],
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.5.2_help",
                  "text" : "This question is optional. It can be used to pre-populate the lead principal investigator site details if this relying site is at the same site as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "drop-down",
                        "display" : "Drop down"
                      }
                    ],
                    "text" : "Drop down"
                  }
                }
              ],
              "linkId" : "in8.5.3",
              "text" : "Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?",
              "type" : "choice",
              "required" : false,
              "answerOption" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "Y",
                    "display" : "Yes"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "N",
                    "display" : "No"
                  },
                  "initialSelected" : true
                }
              ],
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.5.3_help",
                  "text" : "This question is optional. It can be used to pre-populate the lead principal investigator details if this relying site PI is the same PI as the lead principal investigator conducting the study. If you do not want pre-population to occur, you may leave this question blank.",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "drop-down",
                        "display" : "Drop down"
                      }
                    ],
                    "text" : "Drop down"
                  }
                }
              ],
              "linkId" : "in8.5.4",
              "text" : "Is this relying site also considered to be the lead site for the study?",
              "type" : "choice",
              "required" : true,
              "answerOption" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "Y",
                    "display" : "Yes"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "N",
                    "display" : "No"
                  },
                  "initialSelected" : true
                }
              ],
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.5.4_help",
                  "text" : "Indicator that the lead PI site where the study is being conducted is also participating as this relying site",
                  "type" : "display"
                }
              ]
            }
          ]
        },
        {
          "linkId" : "in8.1",
          "text" : "Relying Site Institution",
          "_text" : {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/rendering-style",
                "valueString" : "color:#2a623d;  font-size: 130%"
              }
            ]
          },
          "type" : "group",
          "required" : false,
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression" : {
                    "language" : "text/fhirpath",
                    "expression" : "iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.1').answer.value)"
                  }
                }
              ],
              "linkId" : "in8.1.1",
              "text" : "Relying Institution Name",
              "type" : "string",
              "required" : true,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.1.1_help",
                  "text" : "Name of Institution for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions.",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression" : {
                    "language" : "text/fhirpath",
                    "expression" : "iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.10').answer.value)"
                  }
                }
              ],
              "linkId" : "in8.1.10",
              "text" : "Department Name or Division",
              "type" : "string",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.1.10_help",
                  "text" : "The department name or division for the relying site",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression" : {
                    "language" : "text/fhirpath",
                    "expression" : "iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.3').answer.value)"
                  }
                }
              ],
              "linkId" : "in8.1.3",
              "text" : "Relying Institution Phone",
              "type" : "string",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.1.3_help",
                  "text" : "10-digit phone number, including area code, for the relying institution",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "drop-down",
                        "display" : "Drop down"
                      }
                    ],
                    "text" : "Drop down"
                  }
                },
                {
                  "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression" : {
                    "language" : "text/fhirpath",
                    "expression" : "iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.4').answer.valueCoding)"
                  }
                }
              ],
              "linkId" : "in8.1.4",
              "text" : "Is a Federal Wide Assurance (FWA) Number assigned?",
              "type" : "choice",
              "required" : true,
              "answerOption" : [
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "Y",
                    "display" : "Yes"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "N",
                    "display" : "No"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "NI",
                    "display" : "No Information"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "NAV",
                    "display" : "temporarily unavailable"
                  }
                }
              ],
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.1.4_help",
                  "text" : "DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance.  If the user believes that there is a FWA number assigned but needs to confirm this, select \"temporarily unavailable\". If the user does not know if there is a FWA number assigned, select \"No Information\".",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression" : {
                    "language" : "text/fhirpath",
                    "expression" : "iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.5').answer.value)"
                  }
                }
              ],
              "linkId" : "in8.1.5",
              "text" : "Federal Wide Assurance Number (if assigned)",
              "type" : "integer",
              "enableWhen" : [
                {
                  "question" : "in8.1.4",
                  "operator" : "=",
                  "answerCoding" : {
                    "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                    "code" : "Y"
                  }
                }
              ],
              "enableBehavior" : "all",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.1.5_help",
                  "text" : "If assigned, enter just numeric value of FWA.",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "drop-down",
                        "display" : "Drop down"
                      }
                    ],
                    "text" : "Drop down"
                  }
                }
              ],
              "linkId" : "in8.1.6",
              "text" : "Reliance Status",
              "type" : "choice",
              "required" : true,
              "answerOption" : [
                {
                  "valueCoding" : {
                    "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code" : "APPROVED",
                    "display" : "Approved for reliance"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code" : "DENIED",
                    "display" : "Denied reliance"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code" : "POSSIBLE",
                    "display" : "Potential/possible"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code" : "CANCELLED",
                    "display" : "Cancelled or not participating"
                  }
                },
                {
                  "valueCoding" : {
                    "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                    "code" : "ONHOLD",
                    "display" : "Temporarily on hold"
                  }
                }
              ],
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.1.6_help",
                  "text" : "Status of the reliance agreement",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in8.1_help",
              "text" : "Institution whose IRB agrees to rely on oversite by the sIRB (Reviewing IRB)",
              "type" : "display"
            }
          ]
        },
        {
          "linkId" : "in8.3",
          "text" : "Relying Site Principal Investigator",
          "_text" : {
            "extension" : [
              {
                "url" : "http://hl7.org/fhir/StructureDefinition/rendering-style",
                "valueString" : "color:#2a623d; font-size: 130%"
              }
            ]
          },
          "type" : "group",
          "required" : false,
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression" : {
                    "language" : "text/fhirpath",
                    "expression" : "iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.1').answer.value)"
                  }
                }
              ],
              "linkId" : "in8.3.1",
              "text" : "Relying Site Principal Investigator First Name",
              "type" : "string",
              "required" : true,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.3.1_help",
                  "text" : "First Name or Given Name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression" : {
                    "language" : "text/fhirpath",
                    "expression" : "iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.2').answer.value)"
                  }
                }
              ],
              "linkId" : "in8.3.2",
              "text" : "Relying Site Principal Investigator Last Name",
              "type" : "string",
              "required" : true,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.3.2_help",
                  "text" : "Last name, surname or family name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression" : {
                    "language" : "text/fhirpath",
                    "expression" : "iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.3').answer.value)"
                  }
                }
              ],
              "linkId" : "in8.3.3",
              "text" : "Relying Site Principal Investigator Suffix",
              "type" : "string",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.3.3_help",
                  "text" : "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression" : {
                    "language" : "text/fhirpath",
                    "expression" : "iif(%isSamePIOneRepetition  = 'Y', %resource.descendants().where(linkId = 'in7.3.4').answer.value)"
                  }
                }
              ],
              "linkId" : "in8.3.4",
              "text" : "Academic and Professional Degrees associated with the Relying Site Principal Investigator",
              "type" : "string",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.3.4_help",
                  "text" : "Academic and Professional degrees associated with the relying site principal investigator",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression" : {
                    "language" : "text/fhirpath",
                    "expression" : "iif(%isSamePIOneRepetition  = 'Y', %resource.descendants().where(linkId = 'in7.3.10').answer.value)"
                  }
                }
              ],
              "linkId" : "in8.3.10",
              "text" : "Department Name or Division",
              "type" : "string",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.3.10_help",
                  "text" : "The department name or division for the relying site PI",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression" : {
                    "language" : "text/fhirpath",
                    "expression" : "iif(%isSamePIOneRepetition  = 'Y', %resource.descendants().where(linkId = 'in7.3.5').answer.value)"
                  }
                }
              ],
              "linkId" : "in8.3.5",
              "text" : "Phone",
              "type" : "string",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.3.5_help",
                  "text" : "10-digit phone number, including area code, for the relying site principal investigator",
                  "type" : "display"
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                  "valueExpression" : {
                    "language" : "text/fhirpath",
                    "expression" : "iif(%isSamePIOneRepetition  = 'Y', %resource.descendants().where(linkId = 'in7.3.6').answer.value)"
                  }
                }
              ],
              "linkId" : "in8.3.6",
              "text" : "Email address",
              "type" : "string",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                      "valueCodeableConcept" : {
                        "coding" : [
                          {
                            "system" : "http://hl7.org/fhir/questionnaire-item-control",
                            "code" : "help",
                            "display" : "Help-Button"
                          }
                        ],
                        "text" : "Help-Button"
                      }
                    }
                  ],
                  "linkId" : "in8.3.6_help",
                  "text" : "Email address associated with the relying site principal investigator",
                  "type" : "display"
                }
              ]
            },
            {
              "linkId" : "in8.3.7",
              "text" : "Address of Relying Site Principal Investigator",
              "type" : "group",
              "required" : false,
              "item" : [
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                      "valueExpression" : {
                        "language" : "text/fhirpath",
                        "expression" : "iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.1').answer.value)"
                      }
                    }
                  ],
                  "linkId" : "in8.3.7.1",
                  "text" : "Street Address",
                  "type" : "string",
                  "required" : false,
                  "item" : [
                    {
                      "extension" : [
                        {
                          "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                          "valueCodeableConcept" : {
                            "coding" : [
                              {
                                "system" : "http://hl7.org/fhir/questionnaire-item-control",
                                "code" : "help",
                                "display" : "Help-Button"
                              }
                            ],
                            "text" : "Help-Button"
                          }
                        }
                      ],
                      "linkId" : "in8.3.7.1_help",
                      "text" : "Physical address",
                      "type" : "display"
                    }
                  ]
                },
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                      "valueExpression" : {
                        "language" : "text/fhirpath",
                        "expression" : "iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.2').answer.value)"
                      }
                    }
                  ],
                  "linkId" : "in8.3.7.2",
                  "text" : "City",
                  "type" : "string"
                },
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                      "valueExpression" : {
                        "language" : "text/fhirpath",
                        "expression" : "iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.3').answer.value)"
                      }
                    }
                  ],
                  "linkId" : "in8.3.7.3",
                  "text" : "State",
                  "type" : "string"
                },
                {
                  "extension" : [
                    {
                      "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
                      "valueExpression" : {
                        "language" : "text/fhirpath",
                        "expression" : "iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.4').answer.value)"
                      }
                    }
                  ],
                  "linkId" : "in8.3.7.4",
                  "text" : "Zip Code",
                  "type" : "string",
                  "required" : false
                },
                {
                  "linkId" : "in8.3.7.5",
                  "text" : "Country",
                  "type" : "string",
                  "required" : false,
                  "initial" : [
                    {
                      "valueString" : "United States"
                    }
                  ]
                }
              ]
            },
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in8.3_help",
              "text" : "Principal Investigator responsible for the conduct of the study at a specific relying site research location.",
              "type" : "display"
            }
          ]
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean" : true
            },
            {
              "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
              "valueExpression" : {
                "language" : "text/fhirpath",
                "expression" : "%combinedSitePIUniqueSiteOneRepetition"
              }
            }
          ],
          "linkId" : "in8.9",
          "text" : "Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)",
          "type" : "string",
          "required" : false,
          "readOnly" : true
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean" : true
            },
            {
              "url" : "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
              "valueExpression" : {
                "language" : "text/fhirpath",
                "expression" : "%fullNameDSSitePIOneRepetition"
              }
            }
          ],
          "linkId" : "in8.10",
          "text" : "Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)",
          "type" : "string",
          "required" : false,
          "readOnly" : true
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept" : {
                "coding" : [
                  {
                    "system" : "http://hl7.org/fhir/questionnaire-item-control",
                    "code" : "help",
                    "display" : "Help-Button"
                  }
                ],
                "text" : "Help-Button"
              }
            }
          ],
          "linkId" : "in8_help",
          "text" : "The research site(s) where the Lead Principal Investigator is conducting research should also be entered as relying site(s) here, even if at the same institution as entered above for the Lead Principal Investigator. If the Lead Principal Investigator is only managing a coordinating center or other administrative office for the study, do not enter the site again here.",
          "type" : "display"
        }
      ]
    },
    {
      "linkId" : "DIVIDER5",
      "type" : "display"
    },
    {
      "linkId" : "in9",
      "text" : "FDA exemption and IDE/IND Number",
      "_text" : {
        "extension" : [
          {
            "url" : "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString" : "color:#274e90; font-size: 160%"
          }
        ]
      },
      "type" : "group",
      "item" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept" : {
                "coding" : [
                  {
                    "system" : "http://hl7.org/fhir/questionnaire-item-control",
                    "code" : "drop-down",
                    "display" : "Drop down"
                  }
                ],
                "text" : "Drop down"
              }
            }
          ],
          "linkId" : "in9.1",
          "text" : "Does this study require a FDA exemption?",
          "type" : "choice",
          "answerOption" : [
            {
              "valueCoding" : {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code" : "Y",
                "display" : "Yes"
              }
            },
            {
              "valueCoding" : {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code" : "N",
                "display" : "No"
              }
            }
          ],
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in9.1_help",
              "text" : "Indicator for use of FDA regulated product",
              "type" : "display"
            }
          ]
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept" : {
                "coding" : [
                  {
                    "system" : "http://hl7.org/fhir/questionnaire-item-control",
                    "code" : "drop-down",
                    "display" : "Drop down"
                  }
                ],
                "text" : "Drop down"
              }
            }
          ],
          "linkId" : "in9.2",
          "text" : "Is an IND or IDE being used in this study?",
          "type" : "choice",
          "answerOption" : [
            {
              "valueCoding" : {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code" : "Y",
                "display" : "Yes"
              }
            },
            {
              "valueCoding" : {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code" : "N",
                "display" : "No"
              }
            }
          ],
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in9.2_help",
              "text" : "Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?",
              "type" : "display"
            }
          ]
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
              "valueCodeableConcept" : {
                "coding" : [
                  {
                    "system" : "http://hl7.org/fhir/questionnaire-item-control",
                    "code" : "drop-down",
                    "display" : "Drop down"
                  }
                ],
                "text" : "Drop down"
              }
            }
          ],
          "linkId" : "in9.4",
          "text" : "Please select IND or IDE:",
          "type" : "choice",
          "enableWhen" : [
            {
              "question" : "in9.2",
              "operator" : "=",
              "answerCoding" : {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code" : "Y"
              }
            }
          ],
          "answerOption" : [
            {
              "valueCoding" : {
                "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code" : "IND",
                "display" : "IND"
              }
            },
            {
              "valueCoding" : {
                "system" : "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
                "code" : "IDE",
                "display" : "IDE"
              }
            }
          ],
          "item" : [
            {
              "extension" : [
                {
                  "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
                  "valueCodeableConcept" : {
                    "coding" : [
                      {
                        "system" : "http://hl7.org/fhir/questionnaire-item-control",
                        "code" : "help",
                        "display" : "Help-Button"
                      }
                    ],
                    "text" : "Help-Button"
                  }
                }
              ],
              "linkId" : "in9.4_help",
              "text" : "Select IND for Investigational New Drug  or  IDE for Investigational Device Exemption",
              "type" : "display"
            }
          ]
        },
        {
          "linkId" : "in9.3",
          "text" : "IND/IDE Number",
          "type" : "string",
          "enableWhen" : [
            {
              "question" : "in9.2",
              "operator" : "=",
              "answerCoding" : {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0532",
                "code" : "Y"
              }
            }
          ],
          "required" : false
        }
      ]
    },
    {
      "linkId" : "DIVIDER6",
      "type" : "display"
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
          "valueBoolean" : false
        }
      ],
      "linkId" : "in10",
      "text" : "Questionnaire Version Details",
      "type" : "group",
      "item" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean" : false
            }
          ],
          "linkId" : "in10.1",
          "text" : "Questionnaire Version",
          "type" : "string",
          "required" : true,
          "readOnly" : true,
          "initial" : [
            {
              "valueString" : "2"
            }
          ]
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean" : false
            }
          ],
          "linkId" : "in10.2",
          "text" : "Questionnaire Version Date",
          "type" : "date",
          "required" : true,
          "readOnly" : true,
          "initial" : [
            {
              "valueDate" : "2021-10-18"
            }
          ]
        }
      ]
    },
    {
      "linkId" : "DIVIDER7",
      "type" : "display"
    },
    {
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
          "valueBoolean" : true
        }
      ],
      "linkId" : "ADMIN00",
      "text" : "Administrative Use Only  (will be hidden in the future)",
      "type" : "group",
      "item" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean" : true
            }
          ],
          "linkId" : "ADMIN01",
          "text" : "Link ID prefix",
          "type" : "string",
          "required" : false,
          "initial" : [
            {
              "valueString" : "in"
            }
          ]
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean" : true
            }
          ],
          "linkId" : "ADMIN02",
          "text" : "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any",
          "type" : "string",
          "required" : false,
          "initial" : [
            {
              "valueString" : "temporarily unavailable"
            }
          ]
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean" : true
            }
          ],
          "linkId" : "ADMIN03",
          "text" : "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses",
          "type" : "string",
          "required" : false,
          "initial" : [
            {
              "valueString" : "temporarily unavailable"
            }
          ]
        },
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
              "valueBoolean" : true
            }
          ],
          "linkId" : "ADMIN04",
          "text" : "Questionnaire Response ID of the local considerations Questionnaire Response, if any",
          "type" : "string",
          "required" : false
        }
      ]
    }
  ]
}
XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.