FHIR IG Statistics: Questionnaire/sirb-protocol-questionnaire-populate

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Narrative

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Structure

LinkId	Text	Cardinality	Type	Flags	Description & Constraints
Protocol_questionnaire			Questionnaire		http://hl7.org/fhir/us/sirb/Questionnaire/sirb-protocol-questionnaire-populate#1.0.0
p1	Research Study	0..1	group
p1.1	Study Type	1..1	choice		Options: 2 options Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding
p1.1_help	Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)	0..1	display
p1.2	Intervention	1..1	choice		Enable When: p1.1 = Interventional (Temporary Codes#INT) Options: 4 options
p1.2_help	A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.	0..1	display
p1.3	Does this protocol require a FDA exemption?	0..1	choice		Enable When: p1.2 = Drug/Biologic/Vaccine (Temporary Codes#DBV) p1.2 = Device (Temporary Codes#DEV) Options: 2 options Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding
p1.30	Is an IND or IDE being used in this study?	0..1	choice		Enable When: p1.3 = Yes (expandedYes-NoIndicator#Y) Options: 2 options Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding
p1.30_help	Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?	0..1	display
p1.4	Type of exemption	0..1	choice		Enable When: p1.3 = Yes (expandedYes-NoIndicator#Y) Options: 2 options Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding
p1.4_help	Select Investigational New Drug (IND) or Investigational Device Exemption (IDE)	0..1	display
p1.5	Study Title	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.1').answer.value
p1.5_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
p1.6	Study Title (Short)	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value
p1.6_help	A short study title written in language intended for the lay public.	0..1	display
p1.61	Lead Principal Investigator	0..1	group
p1.61.1	First Name	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value
p1.61.1_help	First or given name of the lead principal investigator	0..1	display
p1.61.2	Last Name	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value
p1.61.2_help	Surname or family name	0..1	display
p1.61.7	Suffix	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value
p1.61.7_help	Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.	0..1	display
p1.61.8	Degree(s)	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value
p1.61.8_help	Professional and Academic degrees of the lead principal investigator	0..1	display
p1.61.3	Department Name	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.10').answer.value
p1.61.4	Address	0..1	group
p1.61.4.1	Street Address	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.1').answer.value
p1.61.4.2	City	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.2').answer.value
p1.61.4.3	State	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.3').answer.value
p1.61.4.4	Zip Code	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.4').answer.value
p1.61.4.5	Country	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.5').answer.value
p1.61.5	Phone	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value
p1.61.5_help	10-digit phone number, including area code	0..1	display
p1.61.6	Email	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value
p1.61_help	The individual(s) designated by the applicant organization/recipient to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the official(s) at the applicant organization/recipient, or as appropriate, to a collaborating organization for the proper conduct of the project, program, or activity including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI. (NIH Definition). https://grants.nih.gov/grants/policy/nihgps/html5/section_1/1.2_definition_of_terms.htm	0..1	display
p1.7	Additional Investigator	0..1	choice		Options: 2 options
p1.7_help	Person(s) designated as the lead PI(s) for the multisite clinical trial; has the appropriate level of authority and responsibility to direct the research being conducted at all sites participating in the clinical trial.	0..1	display
p1.8	Additional Investigator	0..*	group		Enable When: p1.7 = Yes (expandedYes-NoIndicator#Y)
p1.8.1	Additional Investigator Role	0..1	open-choice		Options: 3 options
p1.8.2	First Name	0..1	string
p1.8.2_help	First or given name of the additional investigator	0..1	display
p1.8.3	Last Name	0..1	string
p1.8.3_help	Surname or family name	0..1	display
p1.8.8	Suffix	0..1	string
p1.8.8_help	Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.	0..1	display
p1.8.9	Degree(s)	0..1	string
p1.8.9_help	Professional and Academic degrees of the additional investigator	0..1	display
p1.8.4	Department Name	0..1	string
p1.8.5	Address	0..1	group
p1.8.5.1	Street Address	0..1	string
p1.8.5.2	City	0..1	string
p1.8.5.3	State	0..1	string
p1.8.5.4	Zip Code	0..1	string
p1.8.5.5	Country	0..1	string
p1.8.6	Phone	0..1	string
p1.8.6_help	10-digit phone number, including area code	0..1	display
p1.8.7	Email	0..1	string
p1.9	IRB Protocol Number	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value
p1.9_help	Provided by the sIRB. Will not be available at the time of initial submission.	0..1	display
p1.10	Sponsor Name(s) and Protocol Number	0..1	group
ExternalDataFor_p1.10.1.1	External Data For linkId p1.10.1.1	0..*	open-choice		Expressions: Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').item.where(linkId = 'in5.2').answer.value
p1.10.1	Sponsor	0..*	group
p1.10.1.1	Sponsor Name	0..1	open-choice
p1.10.1.2	Sponsor Protocol Number	0..1	string		Expressions: Calculated Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.where(answer.valueString = %sponsorSelectedThisRepetition)).item.where(linkId = 'in5.4').answer.valueString
p1.10.1.2_help	Unique Protocol Identification Number used by the sponsor.	0..1	display
p1.11	ClinicalTrials.Gov Identifier	0..1	string
p1.11_help	The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419).	0..1	display
p1.12	Grant Title	0..1	text
p1.12_help	Funding Opportunity Title	0..1	display
p1.13	NIH Grant Number	0..1	text
p1.14	IND Number	0..1	string		Enable When: p1.4 = IND (Temporary Codes#IND) Expressions: Calculated Value: iif(%typeExemptionIDEIDN = 'IND', %lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value)
p1.15	IDE Number	0..1	string		Enable When: p1.4 = IDE (Temporary Codes#IDE) Expressions: Calculated Value: iif(%typeExemptionIDEIDN = 'IDE', %lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value)
p1.16	Study Product Name	0..1	text
p1.16_help	Generic, followed by marketed name if applicable	0..1	display
p1.17	Study Product Provider	0..1	text
p1.17_help	e.g. NIH, or company	0..1	display
p1.18	Funding Organization(s), Address and Contact Information	0..1	group
ExternalDataFor_p1.18.1.1	External Data For linkId p1.18.1.1	0..*	open-choice		Expressions: Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').item.where(linkId = 'in5.2').answer.value
p1.18.1	Funding Organization	0..*	group
p1.18.1.1	Name	0..1	open-choice
p1.18.1.2	Address	0..1	group
p1.18.1.2.1	Street Address	0..1	string
p1.18.1.2.2	City	0..1	string
p1.18.1.2.3	State	0..1	string
p1.18.1.2.4	Zip Code	0..1	string
p1.18.1.2.5	Country	0..1	string
p1.18.1.5	Phone	0..1	string		Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in5.2' and answer.value = %fundingOrgName)).item.where(linkId = 'in5.3').answer.value
p1.18.1.5_help	10-digit phone number, including area code	0..1	display
p1.18.1.4	Email	0..1	string
p1.18_help	e.g. NIH, or company	0..1	display
p1.19	Sponsor(s), Address and Contact Information	0..1	group
ExternalDataFor_p1.19.1.1	External Data For linkId p1.19.1.1	0..*	open-choice		Expressions: Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').item.where(linkId = 'in5.2').answer.value
p1.19.1	Sponsor	0..*	group
p1.19.1.1	Name	0..1	open-choice
p1.19.1.2	Department Name	0..1	string
p1.19.1.3	Address	0..1	group
p1.19.1.3.1	Street Address	0..1	string
p1.19.1.3.2	City	0..1	string
p1.19.1.3.3	State	0..1	string
p1.19.1.3.4	Zip Code	0..1	string
p1.19.1.3.5	Country	0..1	string
p1.19.1.4	Email	0..1	string
p1.19.1.5	Phone	0..1	string		Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in5.2' and answer.value = %sponsorOrgNameSelectedThisRepetition)).item.where(linkId = 'in5.3').answer.value
p1.19.1.5_help	10-digit phone number, including area code	0..1	display
p1.19_help	Individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization taking responsibility for and investing in a clinical investigation.	0..1	display
p1.20	Medical Monitor	0..1	group
p1.20_help	Medical expert for the clinical trial	0..1	display
p1.20.1	First Name	0..1	string
p1.20.1_help	First or given name of the medical monitor	0..1	display
p1.20.2	Last Name	0..1	string
p1.20.2_help	Surname or family name	0..1	display
p1.20.6	Suffix	0..1	string
p1.20.6_help	Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.	0..1	display
p1.20.7	Degree(s)	0..1	string
p1.20.7_help	Professional and Academic degrees of the medical monitor	0..1	display
p1.20.3	Phone	0..1	string
p1.20.3_help	10-digit phone number, including area code	0..1	display
p1.20.4	Email	0..1	string
p1.20.5	Address	0..1	group
p1.20.5.1	Street Address	0..1	string
p1.20.5.2	City	0..1	string
p1.20.5.3	State	0..1	text
p1.20.5.4	Zip Code	0..1	string
p1.20.5.5	Country	0..1	string
p1.21	Confidentialty Statement	0..1	text
p1.23	Protocol Version Number	0..1	string
p1.24	Protocol Version Date	0..1	date
p2	Protocol Amendment Summary of Changes Table	0..*	group
p2.1	Affected Section(s)	0..1	text
p2.2	Summary of Revisions Made	0..1	text
p2.3	Rationale	0..1	text
p2.4	Statement of Compliance	1..1	text		Initial Value: string = [Choose Sample Text] (1) [The trial will be carried out in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP) and the following: United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812) National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible for the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the Institutional Review Board (IRB) for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. In addition, all changes to the consent form will be IRB-approved; a determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form.] OR (2) [The trial will be conducted in accordance with International Conference on Harmonisation Good Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and the <specify NIH Institute or Center (IC) > Terms and Conditions of Award. The Principal Investigator will assure that no deviation from, or changes to the protocol will take place without prior agreement from the Investigational New Drug (IND) or Investigational Device Exemption (IDE) sponsor, funding agency and documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. All personnel involved in the conduct of this study have completed Human Subjects Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the IRB for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. All changes to the consent form will be IRB approved; a determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form.]
p2.4_help	Select one of the two statements below. If the study is an intramural NIH study, use the second statement below	0..1	display
p3	Protocol Summary	0..1	group
p3.1	Synopsis	0..1	group
p3.1.1	Title (Full)	0..1	string		Expressions: Initial Value: %resource.item.item.where(linkId = 'p1.5').answer.value
p3.1.2	Title (Short)	0..1	string		Expressions: Initial Value: %resource.item.item.where(linkId = 'p1.6').answer.value
p3.1.3	Study Description	0..1	text
p3.1.3_help	Short description of the protocol, including a brief statement of the study hypothesis. This should be only a few sentences in length. A detailed schematic describing all visits and a schedule of assessments should be included in the Schema and Schedule of Activities	0..1	display
p3.1.4	Objectives	0..1	text
p3.1.4_help	Include the primary and secondary objectives.Theseobjectives should be thesame as the objectives contained in the body of the protocol. These align with Primary Purpose in clinicaltrials.gov	0..1	display
p3.1.5	End Points	0..1	text
p3.1.5_help	Primary endpoint and secondary endpoints.These endpoints should be the same as the endpoints contained in the body of the protocol. These align with Outcome Measures in clinicaltrials.gov	0..1	display
p3.1.6	Accrual Ceiling/Number of Participants (projected-for all sites)	0..1	integer
p3.1.6_help	The total number of subjects expected to complete the study. This includes expected sample size and estimated ineligible persons after signing a screening consent.	0..1	display
p3.1.7	Study Population	0..1	text
p3.1.7_help	Specify sample size, gender, age, demographic group, general health status, and geographic location.	0..1	display
p3.1.8	Phase	0..1	choice		Options: 3 options
p3.1.8_help	Applies to drugs and biologics.	0..1	display
p3.1.9	Description of Sites/Facilities Enrolling Participants	0..1	text
p3.1.9_help	Brief description of planned facilities/participating sites enrolling participants. Indicate number of sites and if the study is intended to include sites outside the United States.	0..1	display
p3.1.10	Description of Study Intervention ( Agent/Procedure)/Investigational Product	0..1	text
p3.1.10_help	Describe the study intervention. If the study interventionis a drug or biologic, include dose and route of administration. For devices,provide a description ofeach important component, ingredient,property and the principle of operation of the device.	0..1	display
p3.1.11	Study Duration	0..1	text
p3.1.11_help	Estimated time (in months) from when the study opens to enrollment until completion of data analyses	0..1	display
p3.1.12	Participant Duration	0..1	text
p3.1.12_help	Time (e.g., in months) it will take for each individual participant to complete all participant visits.	0..1	display
p3.1.13	Methodology	0..1	text
p3.1.13_help	Design attributes such as single blind, double blind or open label; Randomized, placebo or active placebo control; cross-over design, etc.	0..1	display
p3.1.14	Duration of Investigational Product Administration	0..1	text		Enable When: p1.1 = Interventional (Temporary Codes#INT)
p3.1.14_help	Total duration of investigational product administration (including any open-label lead-in, if applicable).	0..1	display
p3.1.15	Key Procedures	0..1	text
p3.1.15_help	Procedures that are required for the study (e.g. harvesting of tumor, vaccine, tumor biopsy and blood draws)	0..1	display
p3.1.16	Main Inclusion/Exclusion Criteria	0..1	text
p3.1.16_help	Entire list of inclusion and exclusion criteria will appear later in the protocol. Only include the key inclusion and exclusion criteria in this section.	0..1	display
p3.1.17	Reference Therapy	0..1	text		Enable When: p1.1 = Interventional (Temporary Codes#INT)
p3.1.17_help	Note if there is a standard reference therapy against which the investigational product is being compared, or if the reference is a placebo	0..1	display
p3.1.18	Statistical Analysis	0..1	text
p3.1.18_help	A very brief description of the main elements of the statistical methodology to be used in the study. Limit this section to discussion of the analysis of the primary endpoint and perhaps the main secondary endpoint.	0..1	display
p3.2	Schema	0..1	group
p3.2.1	Attach schema here	0..1	attachment
p3.2_help	This section is optional. If a schematic is used, it should provide a quick "snapshot" of the study and ideally be limited to one page. Please see the NIH Protocol Templates for Clinical Trials page for the protocol template which contains examples of schematics. A schematic shows the level of detail needed to convey an overview of study design with study-specific information about the study design (e.g., changing method of assignment to study group, adding study arms, visits, etc.) The time point(s) indicated in the schematic should correspond to the time point(s) in Section 7.3, the Study Schedule, e.g., Visit 1, Day 0; Visit 2, Day 30 +/- 7; etc.	0..1	display
p3.3	Schedule of Activities	0..1	group
p3.3.1	Schedule of Activities	0..1	text
p3.3.1_help	Describe the schedule of activities in the text box here or attach a copy of the Schedule of Activities below.	0..1	display
p3.3.3	Schedule of Activities Attachment	0..1	group
p3.3.3.1	Describe the file that is being attached (optional)	0..1	string
p3.3.3.2	Attachment	0..1	attachment
p3.3_help	The schedule of activities must capture the procedures that will be accomplished at each study visit, and all contact, with study participants e.g., telephone contacts. This includes any tests that are used for eligibility, participant randomization or stratification, or decisions on study intervention discontinuation. Only include procedures that contribute to participant eligibility and study objectives and endpoints. Other procedures should be done sparingly and with consideration, as they may add unnecessary complexity and detract from recruitment. Either describe in the text box here or attach a copy of the Schedule of Activities.	0..1	display
p4	Introduction, Background Information and Scientific Rational	0..1	group
p4.1	Background	0..1	group
p4.1.1	Describe the relevant literature and the specific gaps in current knowledge that this study intends to address	0..1	text
p4.1.1_help	Gaps that this study intends to address based on literature	0..1	display
p4.1.2	Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how it will add to existing knowledge	0..1	text
p4.1.2_help	Based on the existing literature and how it will add to existing knowledge	0..1	display
p4.1.3	Describe the relevance and usefulness of the objectives	0..1	text
p4.1.4	Is this the first time the study drug, device, or intervention/procedure will be used in humans.	0..1	choice		Options: 2 options
p4.1.5	If there has been experience with the study drug, device, or intervention/procedure in humans, detail the experience to date	0..1	text		Enable When: p4.1.4 = No (expandedYes-NoIndicator#N)
p4.1.5_help	Details If the intervention/drug/device is not the first time used.	0..1	display
p4.1.6	Investigational Product	0..1	group		Enable When: p1.1 = Interventional (Temporary Codes#INT)
p4.1.6_help	In this section include the name and description of the study intervention (drug, device, biologic, etc.) This section should contain a description of the investigational agent, its make-up, chemical properties and any relevant physical properties, including any available pharmacologic data.Specify the FDA approval status and include the IND Number or justify how the drug meets the IND Exemption criteria if applicable.For device studies this section should include a description of the device, including category of the device, and overview of its intended use or purpose in the research study. Specify the FDA approval status and include the IDE Number or Non-Significant Risk rationale if applicable.	0..1	display
p4.1.6.1	Name and Description	0..1	text
p4.1.6.2	Preclinical Data	0..1	text
p4.1.6.3	Clinical Data to Date	0..1	group
p4.1.6.3.1	Human Pharmacokinetics	0..1	text
p4.1.6.3.2	Clinical Studies in adults	0..1	text
p4.1.6.3.3	Clinical Studies in Children	0..1	text
p4.1.7	Is there an active control group?	0..1	choice		Options: 2 options
p4.1.8	Active Control Group	0..1	group		Enable When: p4.1.7 = Yes (expandedYes-NoIndicator#Y)
p4.1.8.1	Describe any potential bias in the selection of the active control such that there will be an unfair advantage for the investigational intervention. For example, is the active control treatment known to be significantly less effective in this study population than another treatment	0..1	text
p4.1.8.2	Is the sample size and the randomization ratio for this active control study ethically justified with regard to the number of participants who will be exposed to the risks of the study.	0..1	choice		Options: 2 options
p4.1.8.3	Is the active control an established effective intervention?	0..1	choice		Options: 2 options
p4.1.8.4	If no, clarify how it is ethically justified to use this control in the study	0..1	text		Enable When: p4.1.8.3 = No (expandedYes-NoIndicator#N)
p4.2	Study Rationale	0..1	text
p4.2_help	The problems or question and reason for conducting the study. E.g. explain the population, disease, standard of care (if there is one), and limitations of knowledge or available therapy.	0..1	display
p4.3	Risk/Benefit Assessment	0..1	group
p4.3.1	Potential Risks	0..1	group
p4.3.1.1	List the reasonably foreseeable risks, discomforts, hazards, and/or inconveniences to the participants related to their participation in the research, including risk of unintentional loss of confidentiality. Include a description of the probability, magnitude, duration, reversibility, and potential consequences of the risks. Consider physical, psychological, social, legal, and economic risks	0..1	text
p4.3.1.2	State which study interventions may have unknown risks	0..1	text
p4.3.1.3	State which study interventions may have risks to an embryo or fetus (if a participant is or becomes pregnant) or to a nursing infant of a study participant	0..1	text
p4.3.1.4	Describe risks to people other than the participating participant, e.g., risks to family members, friends, others or risks to the community	0..1	text
p4.3.1.5	Are there any risks to study investigators or staff performing the study procedures due to research with high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.):?	0..1	choice		Options: 2 options
p4.3.1.6	Risks to study investigators or staff performing the study procedures due to research with high risk populations (e.g. prisoners, intravenous drug users, patients with major psychiatric issues, etc.)	0..1	group		Enable When: p4.3.1.5 = Yes (expandedYes-NoIndicator#Y)
p4.3.1.6.1	Describe these risks	0..1	text
p4.3.1.6.2	Describe the procedures that will be put in place to minimize these risks	0..1	text
p4.3.1.6.3	Describe how these procedures are adequate for the location where study procedures will be performed	0..1	text
p4.3.1.7	Other risks	0..1	text
p4.3.2	Potential Benefits	0..1	group
p4.3.2.1	Describe the potential benefits that individual participants may experience from taking part in the research. Include the probability, magnitude, and duration of the potential benefits	0..1	text
p4.3.2.1_help	Note: Payments and incentives are not considered benbefits.	0..1	display
p4.3.2.2	Describe any benefit to the population from which the participant is drawn	0..1	text
p4.3.2.3	Describe any benefit to science, society, and humanity in general	0..1	text
p4.3.2.4	Other benefits	0..1	text
p4.3.3	Alternatives to Study Participation	0..1	group
p4.3.3.1	Describe alternatives to participating in this research study (e.g. to decide not participate in the study, alternative treatments, no treatment (palliative care), etc.)	0..1	text
p4.3.3.2	Describe the standard clinical care that may be an alternative	0..1	text
p4.3.3.3	Describe how the participant can receive the research procedures/drug/device used in this study in a non-research setting	0..1	text
p4.3.3.4	Other alternatives to study participation	0..1	text
p5	Study Purpose, Objectives or Specific Aims	0..1	group
p5_help	Describe the purpose, specific aims, or objectives of the study	0..1	display
p5.1	Hypothesis	0..1	text
p5.2	Primary Objectives	0..1	text
p5.2_help	The main question the study seeks to answer.	0..1	display
p5.3	Secondary Objectives	0..1	text
p5.3_help	The secondary objective(s) are goals that will provide further information on the use of the intervention.	0..1	display
p5.4	Tertiary/Exploratory Objectives	0..1	text
p5.4_help	Tertiary/exploratory objective(s) serve as a basis for explaining or supporting findings of primary analyses and for suggesting further hypotheses for later research.	0..1	display
p6	Study Endpoints	0..1	group
p6_help	Precise definitions of the study endpoints and criteria for evaluation	0..1	display
p6.1	Primary Endpoints	0..1	text
p6.1_help	Description of primary endpoints identified in the primary Study Protocol.	0..1	display
p6.1.1	Justification for Endpoints	0..1	text
p6.1.1_help	Briefly explain why the endpoint(s) were chosen.	0..1	display
p6.2	Secondary Endpoints	0..1	text
p6.2.1	Justification for Secondary Endpoints	0..1	text
p6.2.1_help	Briefly explain why the endpoint(s) were chosen.	0..1	display
p6.3	Tertiary Endpoints	0..1	text
p6.3_help	Exploratory endpoints should be specified. Exploratory endpoints may include clinically important events that are expected to occur too infrequently to show a treatment effect or endpoints that for other reasons are thought to be less likely to show an effect but are included to explore new hypotheses.	0..1	display
p6.3.1	Justification for Tertiary Endpoints	0..1	text
p6.3.1_help	Briefly explain why the endpoint(s) were chosen.	0..1	display
p6.4	Primary Safety endpoints	0..1	text
p6.5	Secondary Safety endpoints	0..1	text
p6.6	Predictors and/or comparison groups as appropriate for the stated study objectives/specific aims.	0..1	text
p7	Study Design	0..1	group
p7.1	Overall Design	0..1	text
p7.1_help	The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. A description of the trial design should be consistent with the Protocol Synopsis and Protocol Schema.	0..1	display
p7.2	Scientific Rationale for Study Design	0..1	text
p7.2_help	Describe the rationale for the type and selection of control (e.g. placebo, active drug, dose-response, historical) and study design (e.g., non-inferiority as opposed to superiority). Discuss known or potential problems associated with the control chosen in light of the specific disease and intervention(s) being studied.	0..1	display
p7.3	Justification for Dose	0..1	text		Enable When: p1.2 = Drug/Biologic/Vaccine (Temporary Codes#DBV)
p7.4	Justification for Intervention	0..1	text		Enable When: p1.1 = Interventional (Temporary Codes#INT)
p7.4_help	Provide a justification for the route of administration, planned maximum dosage, and dosing regimen, including starting dose, of the study intervention(s) and control product(s).	0..1	display
p7.5	End of Study Definition	0..1	text
p7.5_help	A clinical trial is considered completed when participants are no longer being examined or the last participant's last study visit has occurred.	0..1	display
p7.6	Screening Activities	0..1	text
p7.7	Study Intervention Activities	0..1	text
p7.8	Follow Up Activities	0..1	text
p7.9	Allocation to Interventional Group	0..1	text
p7.10	Study/Data Collection Instruments	0..1	text
p7.11	Research Setting	0..1	text
p7.15	Study Design Attachments	0..*	group
p7.15_help	Attach documents related to the Study Design here such as Study Intervention Activities descriptions, Follow Up plans and Study/Data Collection Instruments	0..1	display
p7.15.1	Describe the file that is being attached	0..1	string
p7.15.2	Attachment	0..1	attachment
p8	Study Population	0..1	group
p8.1	Participant Selection	0..1	group
p8.1.1	Category/Group (eg. Adults, controls, parents, children)	0..1	text
p8.1.2	Age Range	0..1	text
p8.1.3	Maximum Number to be Consented or Reviewed/Collected(include withdrawals and screen failures)	0..1	integer
p8.1.4	Number Expected to Complete the Study or Needed to Address the Research Question	0..1	integer
p8.1.5	Total Number of participants	0..1	integer
p8.1.6	Overall study sample size (if multisite)	0..1	integer
p9	Study Enrollment and Withdrawal	0..1	group
p9.1	Eligibility Criteria	0..1	group
p9.1.1	Inclusion and Exclusion Criteria	0..1	group
p9.1.1.1	Inclusion Criteria	0..*	text
p9.1.1.1_help	Description of criteria that define participants to include in study	0..1	display
p9.1.1.2	Exclusion Criteria	0..*	text
p9.1.1.2_help	Description of criteria that define participants to exclude in study	0..1	display
p9.1.2	Describe in detail how the eligibility criteria will be assessed and satisfied (e.g., medical record review, physical examination)	0..1	text
p9.1.3	State who will determine eligibility. Note that those who are designated to determine eligibility must have appropriate training, expertise, and oversight, for example a physician PI or Co-I on a biomedical study	0..1	text
p9.1.4	Can study participants participate in another research study while participating in this research study	0..1	choice		Options: 2 options
p9.1.5	Screen Failures	0..1	text
p9.1.5_help	Participants who are consented to participate in the clinical trial, who do not meet one or more criteria required for participation in the trial during the screening procedures, are considered screen failures. Indicate how screen failures will be handled in the trial, including conditions and criteria upon which re-screening is acceptable, when applicable.	0..1	display
p9.1.6	Lifestyle Considerations	0..1	text
p9.1.6_help	Describe any restrictions during any parts of the study pertaining to lifestyle and/or diet (e.g., food and drink restrictions, timing of meals relative to dosing, intake of caffeine, alcohol, or tobacco, or limits on activity), and considerations for household contacts. Describe what action will be taken if prohibited medications, treatments or procedures are indicated for care (e.g., early withdrawal).	0..1	display
p9.1.7	Vulnerable Populations	0..1	group
p9.1.7.1	Can or will pregnant women be enrolled	0..1	choice		Options: 2 options
p9.1.7.2	Enrollment of Pregnant Women	0..1	group		Enable When: p9.1.7.1 = Yes (expandedYes-NoIndicator#Y)
p9.1.7.2.1	Describe any preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, that have been conducted that provide data for assessing potential risks to pregnant women and fetuses	0..1	text
p9.1.7.2.2	Are there any risk to the fetus from the study interventions or procedures.	0..1	choice		Options: 2 options
p9.1.7.2.3	Risks to Fetus	0..1	text		Enable When: p9.1.7.2.2 = Yes (expandedYes-NoIndicator#Y)
p9.1.7.2.4	Do the study interventions or procedures hold out the prospect of direct benefit for the woman or the fetus	0..1	choice		Options: 2 options
p9.1.7.2.5	Describe benefit for the women or fetus	0..1	text		Enable When: p9.1.7.2.4 = Yes (expandedYes-NoIndicator#Y)
p9.1.7.2.6	If there is no prospect of benefit to the fetus, clarify whether the risk to the fetus is NOT greater than Minimal Risk, and whether the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means	0..1	text		Enable When: p9.1.7.2.4 = No (expandedYes-NoIndicator#N)
p9.1.7.2.7	Describe the biomedical knowledge that is expected to result from this research for this population	0..1	text
p9.1.7.2.8	Describe how any risk of this research is the least possible for achieving the objectives of the research	0..1	text
p9.1.7.2.9	Describe how mothers providing consent are informed of the reasonably foreseeable impact of the research on the fetus or neonate	0..1	text
p9.1.7.3	Can or will the research involve neonates of uncertain viability or non-viable neonates?	0..1	choice		Options: 2 options
p9.1.7.31	Research involving neonates of uncertain viability or non-viable neonates	0..1	group		Enable When: p9.1.7.3 = Yes (expandedYes-NoIndicator#Y)
p9.1.7.31.1	Describe any preclinical and clinical studies that have been conducted that provide data for assessing potential risks to neonates	0..1	text
p9.1.7.31.2	Describe the important biomedical knowledge that will be developed from this research and why it cannot be obtained by other means	0..1	text
p9.1.7.31.3	Describe whether there will be added risk to the neonate resulting from the research	0..1	text
p9.1.7.31.4	Describe how individuals providing consent are informed of the reasonably foreseeable impact of the research on the neonate	0..1	text
p9.1.7.31.5	No person shall perform or offer to perform an abortion where part or all of the consideration for said performance is that the fetal remains may be used for experimentation or other kind of research or study	0..1	choice		Options: 2 options
p9.1.7.31.6	Individuals engaged in the research will have no part in determining the viability of a neonate	0..1	choice		Options: 2 options
p9.1.7.31.7	For non-viable neonates, the vital functions of the neonate will not be artificially maintained and that the research will not terminate the heartbeat or respiration of the neonate	0..1	choice		Options: 2 options
p9.1.7.31.8	For neonates of uncertain viability, the research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective	0..1	choice		Options: 2 options
p9.1.7.4	Can or will participants who are not yet adults (neonates, children, teenagers) be enrolled?	0..1	choice		Options: 2 options
p9.1.7.5	Enrollment of participants who are not yet adults (neonates, children, teenagers)	0..1	group		Enable When: p9.1.7.4 = Yes (expandedYes-NoIndicator#Y)
p9.1.7.5.1	I will follow the SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013) to determine whether a prospective participant has or has not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted. (e.g., individuals under the age of 18 years).	0..1	choice		Options: 2 options
p9.1.7.5.1.1	If this SOP will not be followed, describe how this (attainment of legal age for consent or not) will be determined	0..1	text
p9.1.7.5.2	Describe how permission to participate in the study will be obtained from the parents or legal guardians	0..1	text
p9.1.7.5.3	Assent process of children	0..1	group
p9.1.7.5.3.1	Describe waiting period between informing the prospective participant and obtaining the assent	0..1	text
p9.1.7.5.3.2	Describe any process to ensure ongoing assent	0..1	text
p9.1.7.5.3.3	Describe Research team members involved in the assent process	0..1	text
p9.1.7.5.3.4	Describe how long children will have to consider study participation	0..1	text
p9.1.7.5.3.5	Describe steps that will be taken to minimize the possibility of coercion or undue influence	0..1	text
p9.1.7.5.3.6	Describe steps that will be taken to ensure the participants's understanding	0..1	text
p9.1.7.5.3.7	If assent will not be obtained from children, specify why	0..1	text
p9.1.7.5.3.8	Will children reach 18 years of age while in the study?	0..1	choice		Options: 2 options
p9.1.7.5.3.9	Children reaching 18 years of age while in the study	0..1	group		Enable When: p9.1.7.5.3.8 = Yes (expandedYes-NoIndicator#Y)
p9.1.7.5.3.9.1	Describe the plan to obtain written informed consent from the participant at age 18 years	0..1	text
p9.1.7.5.3.9.2	Describe who will be responsible for managing the plan	0..1	text
p9.1.7.5.3.9.3	Describe where the consent discussion will take place	0..1	text
p9.1.7.5.3.9.4	Describe what will happen if the participant cannot be located to provide consent at age 18 years	0..1	text
p9.1.7.6	Can or will minors who are: i)married, widowed, divorced; or ii)Parent of a child; or iii)a member of any of the armed forces; or iv)pregnant or believes herself to be pregnant; or v)living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs be approached for study participation for either themselves or their child?	0..1	choice		Options: 2 options
p9.1.7.7	Enrollment of minors who are: i)married, widowed, divorced; or ii)Parent of a child; or iii)a member of any of the armed forces; or iv)pregnant or believes herself to be pregnant; or v)living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs be approached for study participation for either themselves or their child.	0..1	group		Enable When: p9.1.7.6 = Yes (expandedYes-NoIndicator#Y)
p9.1.7.7.1	Describe how will it be determined that this population has the capacity to consent for this study. Please note that the circumstance of parenthood, pregnancy, etc. may not mean that the person has the same capacity of an adult who can understand the risks, benefits, and alternatives for indicated care. Thus, sound and sensitive clinical judgment that is attentive to both the minorrights and the minoractual competence and needs must be considered, and is to include a determination as to whether involvement of family or other adults familiar to the minor is necessary and appropriate	0..1	text
p9.1.7.7.2	Describe how informed consent will be executed with this population in a way that allows for independent and thoughtful decision-making	0..1	text
p9.1.7.7.3	Describe any additional steps or procedures that will be used when performing informed consent with this population	0..1	text
p9.1.7.8	Can or will cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent be enrolled?	0..1	choice		Options: 2 options
p9.1.7.9	Enrollment of cognitively impaired adults (adults with impaired-decision making capacity) or adults who may lose the capacity to consent	0..1	group		Enable When: p9.1.7.8 = Yes (expandedYes-NoIndicator#Y)
p9.1.7.9.1	Describe whether the research holds out a prospect of direct benefit to the individual participant that is unavailable outside the research context	0..1	text
p9.1.7.9.2	Describe why the objectives of the study cannot be met by enrolling participants who are able to give consent	0..1	text
p9.1.7.9.4	Describe the process to determine whether or not the individual is capable of consent	0..1	text
p9.1.7.9.5	Describe who will determine if the participant is able to provide informed consent	0..1	text
p9.1.7.9.6	Describe how it will be determined whether the participant is able to provide informed consent	0..1	text
p9.1.7.9.7	Describe when and how often (even after obtaining informed consent) it will be determined whether the participant is able to provide informed consent	0..1	text
p9.1.7.9.8	List the individuals from whom permission will be obtained if the participant cannot provide informed consent. Prioritize the list (e.g., durable power of attorney for health care, court appointed guardian for health care decisions, spouse, and adult child.)	0..1	text
p9.1.7.9.9	If it is possible that participants may regain capacity to provide informed consent during the study, describe how frequently this will be assessed and state that participants will be consented to the study in the event that they regain capacity to provide informed consent	0..1	text
p9.1.7.9.10	Process for assent of participants	0..1	group
p9.1.7.9.10.1	Describe whether assent will be required of all, some, or none of the participants. If some, specify which participants will be required to assent and which will not	0..1	text
p9.1.7.9.10.2	If assent will not be obtained from some or all participants, an explanation of why not	0..1	text
p9.1.7.9.10.3	Describe whether assent of the participants will be documented and the process to document assent. The IRB allows the person obtaining assent to document assent on the consent document and does not routinely require assent documents and does not routinely require participants to sign assent documents	0..1	text
p9.1.7.9.11	Provide a description of how the patient will be informed of the potential risks and benefits of the study and any procedures associated with its use	0..1	text
p9.1.7.9.12	Participants will be withdrawn if they appear to be unduly distressed at any time during the study.	0..1	choice		Options: 2 options
p9.1.7.10	Can or will prisoners be enrolled?	0..1	choice		Options: 2 options
p9.1.7.11	Enrollment of prisoners	0..1	group		Enable When: p9.1.7.10 = Yes (expandedYes-NoIndicator#Y)
p9.1.7.11.1	Describe any possible advantages accruing to the Prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired	0..1	text
p9.1.7.11.2	Describe whether the risks involved in the research are commensurate with risks that would be accepted by non-Prisoner volunteers	0..1	text
p9.1.7.11.3	Describe procedures for the selection of participants within the prison which are fair to all Prisoners and immune from arbitrary intervention by prison authorities or Prisoners. Unless the Principal Investigator provides to the Board justification in writing for following some other procedures, control participants must be selected randomly from the group of available Prisoners who meet the characteristics needed for that particular research project	0..1	text
p9.1.7.11.4	Parole boards will not take into account a Prisoner participation in the research in making decisions regarding parole, and each Prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole.	0..1	choice		Options: 2 options
p9.1.7.11.6	If follow-up examination or care of participants after the end of their participation is required, describe the provision for such examination or care, taking into account the varying lengths of individual Prisoners sentences, and for informing participants of this fact	0..1	text
p9.1.7.12	Can or will students and/or employees be enrolled in this research?	0..1	choice		Options: 2 options
p9.1.7.13	Enrollment of students and/or employees	0..1	group		Enable When: p9.1.7.12 = Yes (expandedYes-NoIndicator#Y)
p9.1.7.13.1	Describe the justification for specifically targeting recruitment efforts to enroll students and/or employees	0..1	text
p9.1.7.13.2	Describe how potential coercion will be eliminated	0..1	text
p9.1.7.13.3	Describe the recruitment methods to be applied specifically to students and/or employees. If the same recruitment methods previously described in the protocol will be used, then state that	0..1	text
p9.1.7.13.4	Describe additional safeguards included to protect the rights and welfare of students and employees	0..1	text
p9.1.7.13.5	Describe protections to ensure that a participant's decision about participation and/or early withdrawal from the study will not affect his/her status as a student or employee	0..1	text
p9.1.7.13.6	Submitted a letter from the appropriate institutional official (e.g., Department Chair, Dean, Vice-President) who oversees the students and/or employees attesting to the fact that the employeeor studentparticipation in the research is acceptable and that coercion has been minimized.	0..1	choice		Options: 2 options
p9.1.7.14	Can or will wards of the state and/or children at risk of becoming wards of the state be enrolled (this includes foster children or any child that is in state custody)?	0..1	choice		Options: 2 options
p9.1.7.15	Enrollment of wards of the state and/or children at risk of becoming wards of the state be enrolled (this includes foster children or any child that is in state custody).	0..1	group		Enable When: p9.1.7.14 = Yes (expandedYes-NoIndicator#Y)
p9.1.7.15.1	Describe the justification for recruiting and enrolling this population	0..1	text
p9.1.7.15.2	Describe any additional details about the recruitment methods to be used. If the same recruitment methods previously described in the protocol will be used, then state that	0..1	text
p9.1.7.15.3	Describe any additional details about the informed consent process to be used. If the same informed consent process for enrolling minors previously described in the protocol will be used, then state that	0..1	text
p9.1.7.15.4	Describe how it will be ensured that the appropriate person(s) grants permission for each ward to participate in the research	0..1	text
p9.1.7.15.5	Describe how the research team will know if there has been a change in guardianship status during the course of the research and how permission will be obtained from the new guardian	0..1	text
p9.1.7.15.6	Is the study is greater than minimal risk?	0..1	choice		Options: 2 options
p9.1.7.15.7	Greater than minimal risk study	0..1	group		Enable When: p9.1.7.15.6 = Yes (expandedYes-NoIndicator#Y)
p9.1.7.15.7.1	Describe whether the research is related to their status as wards OR if the research is conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as participants are not wards	0..1	text
p9.1.7.15.7.2	Describe how an advocate will be appointed for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis	0..1	text
p9.1.7.15.7.3	Describe the background and experience of the advocate to act in the best interests of the child for the duration of the childparticipation in the research	0..1	text
p9.1.7.15.7.4	The advocate will not be associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.	0..1	choice		Options: 2 options
p9.2	Strategies for Recruitment and Retention	0..1	group
p9.2.1	Recruitment Methods	0..1	group
p9.2.1.1	Describe when, where, and how potential participants will be recruited	0..1	text
p9.2.1.1_help	Provide a broad overview of the recruitment activities. Specific media, content, duration and scripts will be gathered on the Recruitment Materials Questionnaire.	0..1	display
p9.2.1.2	When participants respond to recruitment material, describe the information that will be collected from participants (e.g. name, telephone number, etc.).	0..1	text
p9.2.1.3	Describe source of participants (for example, patient population, local community, etc.)	0..1	text
p9.2.1.4	Describe methods that will be used to identify potential participants	0..1	text
p9.2.1.5	Describe how the recruitment methods described will be effective in attracting the targeted participant population	0..1	text
p9.3	Duration of Study Participation (If there are sub-studies, include duration of participation in each sub-study.)	0..1	text
p10	Study Intervention	0..1	group		Enable When: p1.1 = Interventional (Temporary Codes#INT)
p10.1	Study Agent	0..1	group
p10.1.1	Study Agent and Control Description	0..1	text
p10.1.2	Receipts/Acquisition	0..1	text
p10.1.2_help	State how the study intervention and control product will be provided to the investigator, including who will be supplying the investigational product and any other protocol dictated medications/devices. If investigational product(s) will be purchased through commercial sources, state this.	0..1	display
p10.1.3	Study Agent Accountability/ Return or Destruction of Investigational Product	0..1	text
p10.1.3_help	Describe plans about how and by whom the study intervention will be distributed, including participation of a drug repository or pharmacy, and plans for disposal of expired or return of unused product.	0..1	display
p10.1.4	Formulation and appearance of Control Product	0..1	text
p10.1.4_help	Describe the formulation and appearance the study intervention. This section should include the name of the manufacturer of the control product.	0..1	display
p10.1.5	Formulation and appearance of Test Product	0..1	text
p10.1.5_help	Describe the formulation and appearance the study intervention. This section should include the name of the manufacturer of the control product.	0..1	display
p10.1.6	Packaging and Labeling	0..1	text
p10.1.6_help	Describe the packaging and labeling of the study intervention and control product, as supplied. Information in this section can usually be obtained from the IB or the package insert, or device labeling.	0..1	display
p10.1.7	Product Storage and Stability	0..1	text
p10.1.7_help	Describe storage and stability requirements (e.g., protection from light, temperature, humidity) for the study intervention and control product. For studies in which multi-dose vials are utilized, provide additional information regarding stability and expiration time after initial use (e.g., the seal is broken).	0..1	display
p10.1.8	Preparation	0..1	text
p10.1.8_help	Description of the preparation of the study intervention and control product, including any preparation required by study staff and/or study participants. Include thawing, diluting, mixing, and reconstitution/preparation instructions, as appropriate. For devices, include any relevant assembly or use instructions.	0..1	display
p10.1.9	Administration and/or Dosing	0..1	text
p10.1.9_help	Describe the procedures for selecting each participant's dose of study intervention and control product. For drugs, that includes the timing of dosing (e.g., time of day, interval), the duration (e.g., the length of time study participants will be administered the study intervention), the planned route of administration (e.g., oral, nasal, intramuscular), and the relation of dosing to meals.	0..1	display
p10.1.10	Route of Administration	0..1	text
p10.1.11	Starting Dose and Dose Escalation Schedule	0..1	text
p10.1.11_help	State the starting dose and schedule of the study intervention and control product, including the maximum and minimum duration for those participants who continue in the study. For example, in some oncology trials for participants with no available therapeutic alternatives, intervention continues even after disease progression. In this instance, consider alternative designs that enable participants to rollover to a continued treatment arm and include appropriate instructions to guide this implementation.	0..1	display
p10.1.12	Dose Adjustments/Modifications/Delays	0..1	text
p10.1.13	Duration of Therapy	0..1	text
p10.1.14	Tracking Dose	0..1	text
p10.1.15	Device Specific Considerations	0..1	text
p10.1.16	Administration Instructions	0..1	text
p10.1.17	Dispensing [authority, requirements]	0..1	text
p10.1.18	Supply of Study Drug at the Site	0..1	text
p10.2	Study Behavioral or Social Intervention(s)	0..1	group		Enable When: p1.2 = Social/Behavioral/educational (SBE) (Temporary Codes#SBE)
p10.2.1	Administration of Intervention	0..1	text
p10.2.2	Procedures for Training Interventionalists and Monitoring Intervention Fidelity	0..1	text
p10.2.3	Assessment of participant Compliance with Study Intervention	0..1	text
p10.3	Study Procedural Intervention(s) Description	0..1	group
p10.3.1	Administration of Procedural Intervention	0..1	text
p10.3.2	Procedures for Training of Clinicians on Procedural Intervention	0..1	text
p10.3.3	Assessment of Clinician and/or Participant Compliance with Study Procedural Intervention	0..1	text
p10.3.3_help	Define how adherence to the protocol (e.g., administration of study intervention, use of device,) will be assessed, and verified (if applicable, e.g., plasma assays, electronic monitoring devices, daily diaries). Include a discussion of what documents are mandatory to complete (e.g., participant drug log) and what source documents/records will be used to calculate study intervention compliance.	0..1	display
p10.4	Participant Compliance and Monitoring	0..1	text
p10.5	Study Intervention/Experimental Manipulation Adherence	0..1	text
p11	Study Intervention Discontinuation and Participant Discontinuation/Withdrawal	0..1	group
p11.1	Discontinuation of Study Intervention	0..1	text
p11.1_help	Participants may withdraw voluntarily from the study or the PI may discontinue a participant from the study. This section should state which adverse events would result in discontinuation of study intervention or participant discontinuation/withdrawal. In addition, participants may discontinue the study intervention, but remain in the study for follow-up, especially for safety and efficacy study endpoints (if applicable). A Case Report Form (CRF) should capture the date and the specific underlying reason for discontinuation of study intervention or participant discontinuation/withdrawal.	0..1	display
p11.2	Participant withdrawal and Termination	0..1	group
p11.2.1	Reasons for Withdrawal or Termination	0..1	text
p11.2.2	Handling of Participant Withdrawal or Termination	0..1	text
p11.2.3	Replacement of participants	0..1	text
p11.3	Lost to Follow-Up	0..1	text
p11.3_help	The protocol should describe the nature and duration of study follow-up. Participants are considered lost to follow-up when they stop reporting to scheduled study visits and cannot be reached to complete all protocol-required study procedures. Describe the plans to minimize loss to follow-up and missing data.	0..1	display
p12	Study Procedures	0..1	group
p12.1	Study Procedures/Evaluations	0..1	group
p12.1.1	Study Specific Procedures	0..1	text
p12.1.2	Standard of Care Study Procedures	0..1	text
p12.2	Laboratory Procedures/Evaluations	0..1	group
p12.2.1	Clinical Laboratory Evaluations	0..1	text
p12.2.2	Research Laboratory Evaluations	0..1	text
p12.2.3	Other Assays or Procedures	0..1	text
p12.2.4	Specimen Preparation, Handling, and Storage	0..1	text
p12.2.5	Specimen Shipment	0..1	text
p12.3	Data Collection and Follow Up for Withdrawn participants	0..1	text
p12.4	Justification for Sensitive Procedures (e.g., use of placebo, medication withdrawal, provocative testing, and deception).	0..1	text
p12.5	Precautionary Medications, Treatments, and Procedures	0..1	text
p12.6	Prohibited Medications, Treatments, and Procedures	0..1	text
p12.7	Prophylactic Medications, Treatments, and Procedures	0..1	text
p12.8	Rescue Medications, Treatments, and Procedures	0..1	text
p12.8_help	List all medications, treatments, and/or procedures that may be provided during the study for "rescue therapy" and relevant instructions about administration of rescue medications.	0..1	display
p12.9	Participant Access to Study Agent at Study Closure	0..1	text
p12.10	Concomitant Medications, Treatments , and Procedures	0..1	text
p12.10_help	This section should be consistent with the medication restrictions in the inclusion/exclusion criteria previously listed. Describe the data that will be recorded related to permitted concomitant medications, supplements, complementary and alternative therapies, treatments, and/or procedures. Include details about when the information will be collected (e.g., screening, all study visits). Describe how allowed concomitant therapy might affect the outcome (e.g., drug-drug interaction, direct effects on the study endpoints) and how the independent effects of concomitant and study interventions could be ascertained.	0..1	display
p13	Schedule of Study Procedures	0..1	group
p13.1	Screening	0..1	text
p13.2	Enrollment/Visit 1/Baseline Visit	0..1	text
p13.3	Intermediate Visits	0..*	text
p13.4	Final Study Visit	0..1	text
p13.5	Withdrawal/Early Termination Visit	0..1	text
p13.6	Unscheduled Visit	0..1	text
p13.7	Follow Up Phase of the Study	0..1	group
p13.7.1	Visit	0..*	text
p13.7.2	End of Study Visit	0..1	text
p13.15	Schedule of Study Procedures Attachments	0..*	group
p13.15_help	Attachments regarding the Schedule of Study Procedures can be attached here.	0..1	display
p13.15.1	Describe the file that is being attached (optional)	0..1	string
p13.15.2	Attachment	0..1	attachment
p14	Assessment of Safety	0..1	group
p14_help	Assessments related to safety and the aspects of the study which are proposed to ensure the safety of trial participants, the risks of the study intervention, and other study procedures and the characteristics of the study population (e.g., vulnerable populations such as children).	0..1	display
p14.1	Specification of Safety Parameters	0..1	group
p14.1.1	Definition of Adverse Events(AE)	0..1	text
p14.1.1_help	Provide the definition of an AE being used for the clinical trial.	0..1	display
p14.1.2	Definition of Serious Adverse Events (SAE)	0..1	text
p14.1.2_help	Provide the definition of an SAE being used for the clinical trial.	0..1	display
p14.1.3	Definition of Unanticipated Problems	0..1	text
p14.1.3_help	This includes any incident or outcome that is not expected in terms of nature, frequency, or severity related to the research procedures and participants.	0..1	display
p14.2	Classification of an Adverse Event	0..1	group
p14.2.1	Severity of an Event	0..1	text
p14.2.1_help	All AEs are assessed by the study clinician using a protocol defined grading system. Describe the method of grading an AE for severity. For example, many toxicity tables are available for use and are adaptable to various study designs.	0..1	display
p14.2.2	Relationship to Study Intervention/Experimental Manipulation	0..1	text
p14.2.2_help	Description of the method of determining the relationship of an AE to a study intervention. If there is any doubt as to whether a clinical observation is an AE, the event should be reported. Some protocols may use a binary assessment (related/not related); others may have a scale of relatedness.	0..1	display
p14.2.3	Expectedness	0..1	text
p14.2.3_help	Description of an adverse event, the nature or severity is not in Investigator Brochure or has been observed, or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere	0..1	display
p14.3	Time Period and Frequencey for Event Assessment and Follow-Up	0..1	text
p14.4	Reporting Procedures	0..1	group
p14.4.1	Notifying the IRB	0..1	group
p14.4.1.1	Adverse Event Reporting	0..1	text
p14.4.1.1_help	Description of the AE reporting procedures, including timeframes	0..1	display
p14.4.1.2	Serious Adverse Event Reporting	0..1	text
p14.4.1.2_help	Description of the SAE reporting procedures, including timeframes	0..1	display
p14.4.1.3	Unanticipated Problem Reporting	0..1	text
p14.4.1.3_help	This section addresses responsibilities of investigators for reporting of UPs. Describe the UP reporting procedures, including timeframes. Further details should be included in a MOP or SOP including a description and a flow chart of when events are reported to various oversight (e.g., DSMB, safety monitoring committee, independent safety monitor) and regulatory s, and what study staff are responsible for completing and signing off on the UP report forms. Institutions engaged in human subjects research conducted or supported by Department of Health and Human Services (DHHS) must have written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and any supporting department or agency head of any unanticipated problem involving risks to subjects or others (45 CFR 46.103(b)(5)). Furthermore, for research covered by an assurance approved for federal wide use by OHRP, DHHS regulations at 45 CFR 46.103(a) require that institutions promptly report any unanticipated problems to OHRP. Refer to the Reportable Events guidance in IRBear for further details.	0..1	display
p14.4.1.4	Reporting of Pregnancy	0..1	text
p14.4.1.4_help	State the study's pregnancy-related policy and procedure. Include appropriate mechanisms for reporting to the DCC or NIH, the IND or IDE sponsor, study leadership, IRB, and regulatory agencies. Provide appropriate modifications to study procedures (e.g., discontinuation of study intervention, while continuing safety follow-up, requesting permission to follow pregnant women to pregnancy outcome).	0..1	display
p14.4.2	Notifyiing the Study Sponsor	0..1	text
p14.4.3	Notifying the FDA	0..1	text
p14.4.4	Notifying Participating Investigators	0..1	text
p14.4.5	Reporting Events to Participants	0..1	text
p14.4.5_help	Describe how participants will be informed about AEs and SAEs, and study-related results on an individual or aggregate level. In addition, describe plans for detecting and managing incidental findings associated with study procedures	0..1	display
p14.4.6	Events of Special Interest	0..1	text
p14.4.6_help	Describe any other events that merit reporting to the sponsor, study leadership, IRB, and regulatory agencies. For example, in oncology trials, secondary malignancies are often captured.	0..1	display
p14.5	Follow Up Report	0..1	text
p14.6	Study Halting/Stopping Rules	0..1	text
p15	Statistical Considerations	0..1	group
p15.1	Statistical and Analytical Plans(SAP)	0..1	text
p15.2	Statistical Hypotheses	0..1	text
p15.2_help	State the formal and testable null and alternative hypotheses for primary and key secondary endpoints, specifying the type of comparison (e.g., superiority, equivalence or non-inferiority, dose response) and time period for which each endpoint will be analyzed.	0..1	display
p15.3	Analysis Datasets	0..1	text
p15.3_help	Clearly identify and describe the analysis datasets (e.g., which participants will be included in each).	0..1	display
p15.4	Populations for Analysis	0..1	text
p15.5	Sample Size Determination	0..1	text
p15.5_help	Include number of participants to recruit, screen, and enroll to have adequate power to test the key hypotheses for the study. Provide all information needed to validate and judge the feasibility of enrolling and following the necessary number of participants. Discuss whether the sample size provides sufficient power for addressing secondary endpoints or exploratory analyses (e.g., sub analyses or moderator analyses involving an interaction term)	0..1	display
p15.6	Description of Statistical Methods	0..1	group
p15.6.1	General Approach	0..1	text
p15.6.2	Analysis of Primary Efficacy Endpoints(s)	0..1	text
p15.6.3	Analysis of Secondary Endpoint(s)	0..1	text
p15.6.4	Safety Analyses	0..1	text
p15.6.4_help	Describe how safety endpoints will be analyzed (e.g., as summary statistics during treatment and/or as change scores from baselines such as shift tables). The information included here should be consistent with the information contained within Assessment of Safety section.	0..1	display
p15.6.5	Adherence and Retention Analyses	0..1	text
p15.6.6	Baseline Descriptive Statistics	0..1	text
p15.6.7	Planned Interim Analyses	0..1	group
p15.6.7.1	Safety Review	0..1	text
p15.6.7.2	Efficacy Review	0..1	text
p15.6.8	Additional Sub-Group Analyses	0..1	text
p15.6.9	Multiple Comparison/Multiplicity	0..1	text
p15.6.10	Tabulation of Individual Response Data	0..1	text
p15.6.11	Exploratory Analyses	0..1	text
p15.6.12	Pharmacokinetic Analysis (if applicable)	0..1	text
p15.7	Sample Size	0..1	text
p15.7_help	Include number of participants to recruit, screen, and enroll to have adequate power to test the key hypotheses for the study. Provide all information needed to validate your calculations and judge the feasibility of enrolling and following the necessary number of participants.Further, present calculations from a suitable range of assumptions to gauge the robustness of the proposed sample size. Discuss whether the sample size provides sufficient power for addressing secondary endpoints or exploratory analyses.	0..1	display
p15.8	Measures to Minimize Bias	0..1	group
p15.8.1	Enrollment/Randomization/Masking Procedures	0..1	text
p15.8.2	Evaluation of Success of Blinding	0..1	text
p15.8.3	Breaking the Study Blind/Participant Code	0..1	text
p16	Supporting Documentation and Operational Considerations	0..1	group
p16.1	Regulatory, Ethical and Study Oversight Considerations	0..1	group
p16.1.1	Protocol Amendments	0..1	text
p16.1.2	Ethical Standard	0..1	text
p16.1.3	Institutional Review Board	0..1	text
p16.1.4	Informed Consent Process	0..1	group
p16.1.4.1	Consent/Assent and Other Informational Documents Provided to Participants	0..1	text
p16.1.4.2	Consent Procedures and Documentation	0..1	group
p16.1.4.2.1	Specify how the research team will assure that participants have sufficient time to consider whether to participate in the research	0..1	text
p16.1.4.2.2	Describe the parental permission process and the child assent process. (If study involves children)	0..1	text
p16.1.4.2.3	Some participants may be vulnerable to coercion or undue influence, such as those who are economically or educationally disadvantaged, mentally disabled, or students (undergraduate, graduate, and medical students) and employees (administrative, clerical, nursing, lab technicians, post-doctoral fellows and house staff, etc.), describe the procedures to ensure the voluntary participation of these individuals	0..1	text
p16.1.4.2.4	Methods of Informed Consent for non-English Speakers	0..1	text
p16.1.4.2.5	Waiver or Alteration of Consent Process	0..1	text
p16.1.4.2.6	HIPAA Authorization	0..1	group
p16.1.4.2.6.1	Participant's Capacity to Give Legally Effective Consent	0..1	text
p16.1.4.3	Indicate where the consent process will take place.	0..1	text
p16.1.5	Participant data and Confidentialty	0..1	group
p16.1.5.1	Research Use of Stored Human Samples, Specimens, or Data	0..1	text
p16.1.5.2	Confidentiality of Research Biospeciemen/Data	0..1	text
p16.1.5.3	Certificate of Confidentiality (if applicable)	0..1	text
p16.1.5.4	Provisions to Protect the Privacy of Participants	0..1	text
p16.1.6	Future Use of Stored Human Specimens and Data	0..1	text
p16.1.7	Study Discontinuation and Closure	0..1	text
p16.1.8	Key Roles and Expertise of Study Team	0..*	group
p16.1.8.1	First Name	0..1	string
p16.1.8.1_help	First or given name	0..1	display
p16.1.8.2	Last Name	0..1	string
p16.1.8.2_help	Surname or family name	0..1	display
p16.1.8.3	Position/Title	0..1	string
p16.1.8.4	Responsibilities	0..1	text
p16.1.8_help	Provide a list of persons, companies, and/or groups serving in key roles in the conduct or oversight of the trial. This should include the sponsormedical expert for the trial (medical monitor), investigator responsible for conducting the trial (principal investigator (PI)), qualified clinician responsible for the siteclinical decisions (site investigator), and any clinical laboratory(ies) or other institutions involved in the trial. Other key roles may include the NIH point of contact (program director or officer), regulatory specialist, biostatistician, data coordinating center (DCC), data management center, data manager, or industry partner.	0..1	display
p16.1.9	Safety Oversight	0..1	text
p16.1.10	Clinical Monitoring	0..1	text
p16.1.11	Quality Assurance and Quality Control	0..1	text
p16.1.12	Data Handling and Record Keeping	0..1	group
p16.1.12.1	Data Quality Control and Reporting	0..1	text
p16.1.12.2	Data Collection and Management Responsibilities	0..1	text
p16.1.12.3	Data Archival	0..1	text
p16.1.12.4	Study Records Retention	0..1	group
p16.1.12.4.1	Photographs, Audio/Video Recordings Retention	0..1	text
p16.1.12.4.2	Data and/or Biological Specimens Access	0..1	text
p16.1.12.4.3	Data and/or Biological Specimens Retention/Banking	0..1	text
p16.1.13	Protocol Deviations	0..1	text
p16.1.14	Publication and Data Sharing Policy	0..1	text
p16.1.15	Conflict of Interest Policy	0..1	text
p16.1.16	Source Documents and Access to Source Data/Documents	0..1	text
p16.1.17	Collections of Photographs, or Audio/Video Recording	0..1	text
p16.2	Prior Approvals/Attachments Requiring Signatures	0..1	group
p16.2.1	Prior Approvals/Attachments Requiring Signatures	0..1	text
p16.2.2	Attachment	0..1	attachment
p16.2.2_help	Attach any prior approvals or documents requiring signatures	0..1	display
p16.3	Additional Considerations	0..1	text
p16.4	Abbreviations and Special Terms	0..1	text
p16.5	Other Supporting Documentation and Operational Considerations Attachments	0..*	group
p16.5.1	Describe the file that is being attached (optional)	0..1	string
p16.5.2	Attachment	0..1	attachment
p16.5.2_help	Other supporting documentation or operational consideration documentation can be attached here, if relevant	0..1	display
p17	Study Administration	0..1	group
p17.1	Setting	0..1	group
p17.1.1	Describe the sites / locations where your research team will conduct the research	0..1	text
p17.2	Registration	0..1	group
p17.2.1	Describe the steps the research team will take to ensure that a participant is appropriately enrolled or registered in the study prior to receiving any study intervention (e.g. describe and submit any protocol eligibility checklist that will be used, specify who on the research team will confirm eligibility and that consent was documented, etc.)	0..1	text
p17.3	Resources Available	0..1	group
p17.3.1	Describe the roles/tasks of each research team member	0..1	text
p17.3.2	Describe the qualifications (e.g., training, experience) of the PI and research team to perform their roles. Provide enough information for the IRB to determine the PI and research team are qualified to conduct the proposed research. Alternatively, you can submit the current CVs for the research team instead	0..1	text
p17.3.3	Describe the coverage plan to address any issues (including participant safety issues) that occur while the PI is away and/or unavailable. The research team member designated to serve as the acting PI in the PIabsence should have similar training and expertise as the PI	0..1	text
p17.3.4	Describe the process to ensure the research team members have adequate oversight and are adequately trained regarding the protocol, study procedures, and their roles and responsibilities	0..1	text
p17.3.5	Are medical or psychological resources that participants might need, such as for emergencies or medical issues, are available for the study?	0..1	choice		Options: 2 options
p17.4	IRB Review	0..1	group
p17.4.1	An appropriate IRB , registered with the OHRP ,review and approve this study.	0..1	choice		Options: 2 options
p17.4.2	Any amendments to the protocol or informed consent documents will be reviewed and approved by the IRB prior to use, unless required to eliminate an apparent immediate hazard to participants?	0..1	choice		Options: 2 options
p17.5	Community-Based Participatory Research/Field Research	0..1	group
p17.5.1	Can or will this study involve community-based participatory research?	0..1	choice		Options: 2 options
p17.5.2	Community-based participatory research	0..1	group		Enable When: p17.5.1 = Yes (expandedYes-NoIndicator#Y)
p17.5.2.1	Describe the communities that will be involved in this research	0..1	text
p17.5.2.2	Describe the composition and involvement of any community advisory board	0..1	text
p17.5.2.3	Describe the involvement of the community in the design, protocol development, informed consent process, access to data and samples, and conduct of the research	0..1	text
p17.5.2.4	Describe the plans on dissemination and publication of study results which are in agreement with the community	0..1	text
p17.6	Multi Site Research	0..1	group
p17.6.1	Describe the plan for tracking IRB approval of documents and consent forms for each site	0..1	text
p17.6.2	Name of the sponsor(s) and Contract Research Organization (CRO)	0..1	group
ExternalDataFor_p17.6.2.1	External Data For linkId p17.6.2.1	0..*	open-choice		Expressions: Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'SFS').item.where(linkId = 'in5.2').answer.value
p17.6.2.1	Name of the sponsor(s)	0..*	open-choice
p17.6.2.2	Name of the Contract Research Organization (CRO)	0..1	string		Expressions: Initial Value: %lookupInitiateStudy.item.where(linkId = 'in5' and item.answer.value.code = 'CRO').item.where(linkId = 'in5.2').answer.value
p17.6.3	Describe the training that will be provided to the enrolling sites staff prior to protocol implementation at that study site and throughout the course of the study. Include the type of training, e.g., study meetings, teleconferences, etc., as well as who will provide the training and how it will be documented	0..1	text
p17.6.4	Describe the plan for ensuring that amendments to the Coordinating Center template protocol and template consent forms will be communicated to all sites	0..1	text
p17.6.5	Describe the plan for ensuring that all sites have the most current version of the protocol and consent forms	0..1	text
p17.6.6	Describe the plan for collection and management of data from all sites. Specify if data will be shared outside (e.g., with other investigators, sponsor, etc.) and how the data will be shared (e.g. how data will be received from and distributed to other sites as needed). If available, please provide the Data Sharing Plan or Policy	0..1	text
p17.6.7	Plan to manage and/or monitor each site's study conduct including enrollment, research events, withdrawals and protocol deviations	0..1	group
p17.6.7.1	Describe how the Coordinating Center will monitor each site's study conduct during the different phases of the study (e.g. remotely, in-person visits, reports, etc.)	0..1	text
p17.6.7.2	Describe whether monitoring visits will be conducted. If so, how often? What will the site monitoring visits entail?	0..1	text
p17.6.8	Describe the plan for processing, reporting and evaluating unanticipated problems, protocol violations, deviations, and serious adverse events from all sites to the IRB, funder, and federal agencies (e.g. FDA)	0..1	text
p17.6.9	Plan for handling of the investigational product (drug/device/biologic) at each site (if applicable)	0..1	group
p17.6.9.1	Describe how they will be provided to each enrolling site	0..1	text
p17.6.9.2	Describe how dispensing will be monitored	0..1	text
p17.6.9.3	Describe what investigational product accountability procedures will be implemented	0..1	text
p17.6.10	Describe the procedures for study closures and early site termination	0..1	text
p17.6.11	Describe any collaborations not described above, such as [institution] investigators with multiple affiliations that would engage other institutions in research (e.g., [institution] is paying another institution for the research, the research is being conducted on behalf of another institution)	0..1	text
p17.7	Key Roles and Study Governance	0..1	text
p18	Study Finances	0..1	group
p18.1	Funding Source	0..1	text
p18.2	Costs to the participant	0..1	text
p18.3	Participant Reimbursements or Payments	0..1	text
p18.4	Compensation for Research-Related Injury	0..1	text
p19	References	0..1	group
p19.1	List any references here, unless already cited.	0..1	text
p19.2	Reference list attachment (optional)	0..1	group
p19.2.1	Describe the file that is being attached (optional)	0..1	string
p19.2.2	Attachment	0..1	attachment
p19.2_help	Reference list can be attached here	0..1	display
p25	Other Attachments to the Protocol	0..1	group
p25.1	Other Attachment(s) to the Protocol	0..*	group
p25.1.1	Describe the file that is being attached	0..1	string
p25.1.2	Attachment	0..1	attachment
p25.1_help	Attach any other relevant materials here, if not attached in other sections of the form	0..1	display
ADMIN00	Administrative Use Only	0..1	group
ADMIN01	Link ID prefix	0..1	string		Initial Value: string = p
ADMIN02	Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any	0..1	string		Initial Value: string = temporarily unavailable Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value
ADMIN03	ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any	0..1	string		Initial Value: string = temporarily unavailable Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value
ADMIN04	Questionnaire Response ID of the local considerations Questionnaire Response, if any	0..1	string
Documentation for this format

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Option Sets

Answer options for p1.1

• http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#INT ("Interventional")
• http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#OBS ("Observational")

Answer options for p1.2

• http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DBV ("Drug/Biologic/Vaccine")
• http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DEV ("Device")
• http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#SBE ("Social/Behavioral/educational (SBE)")
• http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PRO ("Procedural")

Answer options for p1.3

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p1.30

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p1.4

• http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IND ("IND")
• http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IDE ("IDE")

Answer options for p1.7

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p1.8.1

• http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#COPI ("Co-Principal Investigator")
• http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#COI ("Co-Investigator")
• http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PD ("Program Director")

Answer options for p3.1.8

• http://terminology.hl7.org/CodeSystem/research-study-phase#phase-2 ("Phase 2")
• http://terminology.hl7.org/CodeSystem/research-study-phase#phase-3 ("Phase 3")
• http://terminology.hl7.org/CodeSystem/research-study-phase#phase-4 ("Phase 4")

Answer options for p4.1.4

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p4.1.7

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p4.1.8.2

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p4.1.8.3

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p4.3.1.5

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.4

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.1

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.2.2

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.2.4

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.3

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.31.5

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.31.6

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.31.7

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.31.8

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.4

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.5.1

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.5.3.8

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.6

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.8

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.9.12

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.10

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.11.4

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.12

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.13.6

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.14

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.15.6

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p9.1.7.15.7.4

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p17.3.5

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p17.4.1

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p17.4.2

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")

Answer options for p17.5.1

• http://terminology.hl7.org/CodeSystem/v2-0532#Y ("Yes")
• http://terminology.hl7.org/CodeSystem/v2-0532#N ("No")