FHIR IG analytics| Package | hl7.fhir.us.sirb |
| Resource Type | QuestionnaireResponse |
| Id | QuestionnaireResponse-initiate-study-populate-exampleQR.json |
| FHIR Version | R4 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
| LinkId | Text | Definition | Answer |
|---|---|---|---|
  initiate-study-populate-exampleQR | QuestionnaireResponse | ||
  in1 | Research Study Details | ||
  in1.1 | Study Title | A clinical study of the efficacy of Drug A for arthritis | |
| in1.2 | Study Title (Short) | Study of Drug A for arthritis | |
| in1.3 | IRB Protocol Number | PRO098765 | |
 in1.4 | Study Type | Temporary Codes INT: Interventional | |
| in5 | Other Organization(s) Involved | ||
| in5.1 | Relationship Type | Temporary Codes SFS: Sponsor or Funding Source | |
| in5.2 | Organization Name | National Government Funder | |
| in5.3 | Phone | 800-123-1234 | |
| in5.4 | Sponsor or Funding Source Protocol Number, if applicable | Gov-123456 | |
| in5.5 | Other Organization Name, Relationship Type, Phone and Protocol Number (read-only) | National Government Funder | 800-123-1234 | Gov-123456 | Sponsor or Funding Source | |
| in5.6 | Protocol Number with Organization Name (read-only) | Gov-123456 (National Government Funder) | |
| in5 | Other Organization(s) Involved | ||
| in5.1 | Relationship Type | Temporary Codes SFS: Sponsor or Funding Source | |
| in5.2 | Organization Name | Organization of Arthritis Patients Foundation | |
| in5.3 | Phone | 123-123-1234 | |
| in5.5 | Other Organization Name, Relationship Type, Phone and Protocol Number (read-only) | Organization of Arthritis Patients Foundation | 123-123-1234 | | Sponsor or Funding Source | |
| in5.6 | Protocol Number with Organization Name (read-only) | (Organization of Arthritis Patients Foundation) | |
| in5 | Other Organization(s) Involved | ||
| in5.1 | Relationship Type | Temporary Codes CRO: Contract Research Organization (CRO) | |
| in5.2 | Organization Name | Sample CRO, Inc. | |
| in5.3 | Phone | 234-123-1234 | |
| in5.5 | Other Organization Name, Relationship Type, Phone and Protocol Number (read-only) | Sample CRO, Inc. | 234-123-1234 | | Contract Research Organization (CRO) | |
| in5.6 | Protocol Number with Organization Name (read-only) | (Sample CRO, Inc.) | |
| in6 | sIRB (Reviewing Institution) | ||
| in6.1 | sIRB (Reviewing Institution) Name | X Pharmaceutical Research IRB | |
| in6.3 | Institution Street Address | 210 Research Drive | |
| in6.4 | Institution City | Sample City | |
| in6.5 | Institution State | NC | |
| in6.6 | Institution Zip Code | 27612 | |
| in6.7 | Institution Country | United States | |
| in6.8 | Is a Federal Wide Assurance (FWA) Number assigned? | expandedYes-NoIndicator Y: Yes | |
| in6.9 | Federal Wide Assurance Number (if assigned) | 12345 | |
| in6.11 | Is the sIRB a 3rd party institution? | expandedYes-NoIndicator Y: Yes | |
| in7 | Lead Principal Investigator | ||
| in7.1 | Lead Principal Investigator Institution | ||
| in7.1.1 | Lead Principal Investigator Institution Name | Sample University Medical Center | |
| in7.1.4 | Is a Federal Wide Assurance (FWA) Number assigned? | expandedYes-NoIndicator Y: Yes | |
| in7.1.5 | Federal Wide Assurance Number (if assigned) | 56789 | |
| in7.3 | Lead Principal Investigator | ||
| in7.3.1 | Lead Principal Investigator First Name | Jane | |
| in7.3.2 | Lead Principal Investigator Last Name | Doe | |
| in7.3.4 | Academic and Professional Degrees associated with the Lead Principal Investigator | MD | |
| in7.3.10 | Department Name or Division | Orthopedics | |
| in7.3.5 | Phone | 567-123-1234 | |
| in7.3.6 | Email address | drjanedoe@sampleuniversity.edu | |
| in7.3.7 | Address of Lead Principal Investigator | ||
 in7.3.7.1 | Street Address | 105 Sample University Ct. | |
| in7.3.7.2 | City | Sample City | |
| in7.3.7.3 | State | NC | |
| in7.3.7.4 | Zip Code | 27612 | |
| in7.3.7.5 | Country | United States | |
| in7.9 | Lead Principal Investigator Unique Site (read-only) | Sample University Medical Center | | Jane Doe, MD | Sample City, NC | |
| in7.10 | Lead Principal Investigator Full Name, Suffix and Degrees | Jane Doe, MD | |
| in8 | Relying Site(s) | ||
| in8.5 | Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator | ||
| in8.5.1 | Is this relying site at the same institution as where the lead principal investigator is conducting the study? | expandedYes-NoIndicator Y: Yes | |
| in8.5.2 | Is this relying site at the same site as where the lead principal investigator is conducting the study? | expandedYes-NoIndicator Y: Yes | |
| in8.5.3 | Is the relying site PI for this site the same PI as the lead principal investigator conducting the study? | expandedYes-NoIndicator Y: Yes | |
| in8.5.4 | Is this relying site also considered to be the lead site for the study? | expandedYes-NoIndicator Y: Yes | |
| in8.1 | Relying Site Institution | ||
| in8.1.1 | Relying Institution Name | Sample University Medical Center | |
| in8.1.4 | Is a Federal Wide Assurance (FWA) Number assigned? | expandedYes-NoIndicator Y: Yes | |
| in8.1.5 | Federal Wide Assurance Number (if assigned) | 56789 | |
| in8.1.6 | Reliance Status | Temporary Codes APPROVED: Approved for reliance | |
| in8.3 | Relying Site Principal Investigator | ||
| in8.3.1 | Relying Site Principal Investigator First Name | Jane | |
| in8.3.2 | Relying Site Principal Investigator Last Name | Doe | |
| in8.3.4 | Academic and Professional Degrees associated with the Relying Site Principal Investigator | MD | |
| in8.3.10 | Department Name or Division | Orthopedics | |
| in8.3.5 | Phone | 567-123-1234 | |
| in8.3.6 | Email address | drjanedoe@sampleuniversity.edu | |
| in8.3.7 | Address of Relying Site Principal Investigator | ||
| in8.3.7.1 | Street Address | 105 Sample University Ct. | |
| in8.3.7.2 | City | Sample City | |
| in8.3.7.3 | State | NC | |
| in8.3.7.4 | Zip Code | 27612 | |
| in8.3.7.5 | Country | United States | |
| in8.9 | Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only) | Sample University Medical Center | | Jane Doe, MD | Sample City, NC | |
| in8.10 | Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only) | Jane Doe, MD | |
| in8 | Relying Site(s) | ||
| in8.5 | Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator | ||
| in8.5.1 | Is this relying site at the same institution as where the lead principal investigator is conducting the study? | expandedYes-NoIndicator N: No | |
| in8.5.3 | Is the relying site PI for this site the same PI as the lead principal investigator conducting the study? | expandedYes-NoIndicator N: No | |
| in8.5.4 | Is this relying site also considered to be the lead site for the study? | expandedYes-NoIndicator N: No | |
| in8.1 | Relying Site Institution | ||
| in8.1.1 | Relying Institution Name | Test Example University | |
| in8.1.3 | Relying Institution Phone | 6781233456 | |
| in8.1.4 | Is a Federal Wide Assurance (FWA) Number assigned? | expandedYes-NoIndicator Y: Yes | |
| in8.1.5 | Federal Wide Assurance Number (if assigned) | 34567 | |
| in8.1.6 | Reliance Status | Temporary Codes POSSIBLE: Potential/possible | |
| in8.3 | Relying Site Principal Investigator | ||
| in8.3.1 | Relying Site Principal Investigator First Name | Xi-Yang | |
| in8.3.2 | Relying Site Principal Investigator Last Name | Lee | |
| in8.3.3 | Relying Site Principal Investigator Suffix | Jr. | |
| in8.3.4 | Academic and Professional Degrees associated with the Relying Site Principal Investigator | MD, PhD | |
| in8.3.5 | Phone | 6781233456 | |
| in8.3.6 | Email address | XiYangLee@teu.med.edu | |
| in8.3.7 | Address of Relying Site Principal Investigator | ||
| in8.3.7.1 | Street Address | 200 Test Example Circle | |
| in8.3.7.2 | City | Example | |
| in8.3.7.3 | State | MA | |
| in8.3.7.4 | Zip Code | 67890 | |
| in8.3.7.5 | Country | United States | |
| in8.9 | Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only) | Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA | |
| in8.10 | Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only) | Xi-Yang Lee, Jr., MD, PhD | |
| in8 | Relying Site(s) | ||
| in8.5 | Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator | ||
| in8.5.1 | Is this relying site at the same institution as where the lead principal investigator is conducting the study? | expandedYes-NoIndicator N: No | |
| in8.5.3 | Is the relying site PI for this site the same PI as the lead principal investigator conducting the study? | expandedYes-NoIndicator N: No | |
| in8.5.4 | Is this relying site also considered to be the lead site for the study? | expandedYes-NoIndicator N: No | |
| in8.1 | Relying Site Institution | ||
| in8.1.1 | Relying Institution Name | Central Campus Test University | |
| in8.1.4 | Is a Federal Wide Assurance (FWA) Number assigned? | expandedYes-NoIndicator NI: No Information | |
| in8.1.6 | Reliance Status | Temporary Codes POSSIBLE: Potential/possible | |
| in8.3 | Relying Site Principal Investigator | ||
| in8.3.1 | Relying Site Principal Investigator First Name | Maria | |
| in8.3.2 | Relying Site Principal Investigator Last Name | Smith | |
| in8.3.4 | Academic and Professional Degrees associated with the Relying Site Principal Investigator | PhD | |
| in8.3.5 | Phone | 8901231234 | |
| in8.3.6 | Email address | maria.smith@CCTU.med.edu | |
| in8.3.7 | Address of Relying Site Principal Investigator | ||
| in8.3.7.1 | Street Address | 200 Central St. | |
| in8.3.7.2 | City | Central | |
| in8.3.7.3 | State | MI | |
| in8.3.7.4 | Zip Code | 23456 | |
| in8.3.7.5 | Country | United States | |
| in8.9 | Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only) | Central Campus Test University | | Maria Smith, PhD | Central, MI | |
| in8.10 | Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only) | Maria Smith, PhD | |
| in9 | FDA exemption and IDE/IND Number | ||
| in9.1 | Does this study require a FDA exemption? | expandedYes-NoIndicator Y: Yes | |
| in9.2 | Is an IND or IDE being used in this study? | expandedYes-NoIndicator Y: Yes | |
| in9.4 | Please select IND or IDE: | Temporary Codes IND: IND | |
| in9.3 | IND/IDE Number | 432fdw512432fqsdf | |
| in10 | Questionnaire Version Details | ||
| in10.1 | Questionnaire Version | 2 | |
| in10.2 | Questionnaire Version Date | 2021-10-18 | |
| ADMIN00 | Administrative Use Only (will be hidden in the future) | ||
| ADMIN01 | Link ID prefix | in | |
| ADMIN02 | Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any | initiate-study-populate-exampleQR | |
| ADMIN03 | ID of the Research Study FHIR Resource associated with the study Questionnaire Responses | ResearchStudyExample-sIRB | |
| Documentation for this format | |||
FHIR
FHIRsmith{
"resourceType": "QuestionnaireResponse",
"id": "initiate-study-populate-exampleQR",
"meta": {
"versionId": "3",
"lastUpdated": "2022-02-25T22:56:02.598+00:00"
},
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/workflow-researchStudy",
"valueReference": {
"reference": "ResearchStudy/ResearchStudyExample-sIRB",
"display": "ResearchStudyExample-sIRB"
}
}
],
"questionnaire": "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire-populate",
"status": "completed",
"authored": "2022-02-25T22:55:38.773Z",
"item": [
{
"linkId": "in1",
"text": "Research Study Details",
"item": [
{
"linkId": "in1.1",
"text": "Study Title",
"answer": [
{
"valueString": "A clinical study of the efficacy of Drug A for arthritis"
}
]
},
{
"linkId": "in1.2",
"text": "Study Title (Short)",
"answer": [
{
"valueString": "Study of Drug A for arthritis"
}
]
},
{
"linkId": "in1.3",
"text": "IRB Protocol Number",
"answer": [
{
"valueString": "PRO098765"
}
]
},
{
"linkId": "in1.4",
"text": "Study Type",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "INT",
"display": "Interventional"
}
}
]
}
]
},
{
"linkId": "in5",
"text": "Other Organization(s) Involved",
"item": [
{
"linkId": "in5.1",
"text": "Relationship Type",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "SFS",
"display": "Sponsor or Funding Source"
}
}
]
},
{
"linkId": "in5.2",
"text": "Organization Name",
"answer": [
{
"valueString": "National Government Funder"
}
]
},
{
"linkId": "in5.3",
"text": "Phone",
"answer": [
{
"valueString": "800-123-1234"
}
]
},
{
"linkId": "in5.4",
"text": "Sponsor or Funding Source Protocol Number, if applicable",
"answer": [
{
"valueString": "Gov-123456"
}
]
},
{
"linkId": "in5.5",
"text": "Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)",
"answer": [
{
"valueString": "National Government Funder | 800-123-1234 | Gov-123456 | Sponsor or Funding Source"
}
]
},
{
"linkId": "in5.6",
"text": "Protocol Number with Organization Name (read-only)",
"answer": [
{
"valueString": "Gov-123456 (National Government Funder)"
}
]
}
]
},
{
"linkId": "in5",
"text": "Other Organization(s) Involved",
"item": [
{
"linkId": "in5.1",
"text": "Relationship Type",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "SFS",
"display": "Sponsor or Funding Source"
}
}
]
},
{
"linkId": "in5.2",
"text": "Organization Name",
"answer": [
{
"valueString": "Organization of Arthritis Patients Foundation"
}
]
},
{
"linkId": "in5.3",
"text": "Phone",
"answer": [
{
"valueString": "123-123-1234"
}
]
},
{
"linkId": "in5.5",
"text": "Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)",
"answer": [
{
"valueString": "Organization of Arthritis Patients Foundation | 123-123-1234 | | Sponsor or Funding Source"
}
]
},
{
"linkId": "in5.6",
"text": "Protocol Number with Organization Name (read-only)",
"answer": [
{
"valueString": "(Organization of Arthritis Patients Foundation)"
}
]
}
]
},
{
"linkId": "in5",
"text": "Other Organization(s) Involved",
"item": [
{
"linkId": "in5.1",
"text": "Relationship Type",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "CRO",
"display": "Contract Research Organization (CRO)"
}
}
]
},
{
"linkId": "in5.2",
"text": "Organization Name",
"answer": [
{
"valueString": "Sample CRO, Inc."
}
]
},
{
"linkId": "in5.3",
"text": "Phone",
"answer": [
{
"valueString": "234-123-1234"
}
]
},
{
"linkId": "in5.5",
"text": "Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)",
"answer": [
{
"valueString": "Sample CRO, Inc. | 234-123-1234 | | Contract Research Organization (CRO)"
}
]
},
{
"linkId": "in5.6",
"text": "Protocol Number with Organization Name (read-only)",
"answer": [
{
"valueString": "(Sample CRO, Inc.)"
}
]
}
]
},
{
"linkId": "in6",
"text": "sIRB (Reviewing Institution)",
"item": [
{
"linkId": "in6.1",
"text": "sIRB (Reviewing Institution) Name",
"answer": [
{
"valueString": "X Pharmaceutical Research IRB"
}
]
},
{
"linkId": "in6.3",
"text": "Institution Street Address",
"answer": [
{
"valueString": "210 Research Drive"
}
]
},
{
"linkId": "in6.4",
"text": "Institution City",
"answer": [
{
"valueString": "Sample City"
}
]
},
{
"linkId": "in6.5",
"text": "Institution State",
"answer": [
{
"valueString": "NC"
}
]
},
{
"linkId": "in6.6",
"text": "Institution Zip Code",
"answer": [
{
"valueString": "27612"
}
]
},
{
"linkId": "in6.7",
"text": "Institution Country",
"answer": [
{
"valueString": "United States"
}
]
},
{
"linkId": "in6.8",
"text": "Is a Federal Wide Assurance (FWA) Number assigned?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "in6.9",
"text": "Federal Wide Assurance Number (if assigned)",
"answer": [
{
"valueInteger": 12345
}
]
},
{
"linkId": "in6.11",
"text": "Is the sIRB a 3rd party institution?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
}
]
},
{
"linkId": "in7",
"text": "Lead Principal Investigator",
"item": [
{
"linkId": "in7.1",
"text": "Lead Principal Investigator Institution",
"item": [
{
"linkId": "in7.1.1",
"text": "Lead Principal Investigator Institution Name",
"answer": [
{
"valueString": "Sample University Medical Center"
}
]
},
{
"linkId": "in7.1.4",
"text": "Is a Federal Wide Assurance (FWA) Number assigned?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "in7.1.5",
"text": "Federal Wide Assurance Number (if assigned)",
"answer": [
{
"valueInteger": 56789
}
]
}
]
},
{
"linkId": "in7.3",
"text": "Lead Principal Investigator",
"item": [
{
"linkId": "in7.3.1",
"text": "Lead Principal Investigator First Name",
"answer": [
{
"valueString": "Jane"
}
]
},
{
"linkId": "in7.3.2",
"text": "Lead Principal Investigator Last Name",
"answer": [
{
"valueString": "Doe"
}
]
},
{
"linkId": "in7.3.4",
"text": "Academic and Professional Degrees associated with the Lead Principal Investigator",
"answer": [
{
"valueString": "MD"
}
]
},
{
"linkId": "in7.3.10",
"text": "Department Name or Division",
"answer": [
{
"valueString": "Orthopedics"
}
]
},
{
"linkId": "in7.3.5",
"text": "Phone",
"answer": [
{
"valueString": "567-123-1234"
}
]
},
{
"linkId": "in7.3.6",
"text": "Email address",
"answer": [
{
"valueString": "drjanedoe@sampleuniversity.edu"
}
]
},
{
"linkId": "in7.3.7",
"text": "Address of Lead Principal Investigator",
"item": [
{
"linkId": "in7.3.7.1",
"text": "Street Address",
"answer": [
{
"valueString": "105 Sample University Ct."
}
]
},
{
"linkId": "in7.3.7.2",
"text": "City",
"answer": [
{
"valueString": "Sample City"
}
]
},
{
"linkId": "in7.3.7.3",
"text": "State",
"answer": [
{
"valueString": "NC"
}
]
},
{
"linkId": "in7.3.7.4",
"text": "Zip Code",
"answer": [
{
"valueString": "27612"
}
]
},
{
"linkId": "in7.3.7.5",
"text": "Country",
"answer": [
{
"valueString": "United States"
}
]
}
]
}
]
},
{
"linkId": "in7.9",
"text": "Lead Principal Investigator Unique Site (read-only)",
"answer": [
{
"valueString": "Sample University Medical Center | | Jane Doe, MD | Sample City, NC"
}
]
},
{
"linkId": "in7.10",
"text": "Lead Principal Investigator Full Name, Suffix and Degrees",
"answer": [
{
"valueString": "Jane Doe, MD"
}
]
}
]
},
{
"linkId": "in8",
"text": "Relying Site(s)",
"item": [
{
"linkId": "in8.5",
"text": "Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator",
"item": [
{
"linkId": "in8.5.1",
"text": "Is this relying site at the same institution as where the lead principal investigator is conducting the study?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "in8.5.2",
"text": "Is this relying site at the same site as where the lead principal investigator is conducting the study?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "in8.5.3",
"text": "Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "in8.5.4",
"text": "Is this relying site also considered to be the lead site for the study?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
}
]
},
{
"linkId": "in8.1",
"text": "Relying Site Institution",
"item": [
{
"linkId": "in8.1.1",
"text": "Relying Institution Name",
"answer": [
{
"valueString": "Sample University Medical Center"
}
]
},
{
"linkId": "in8.1.4",
"text": "Is a Federal Wide Assurance (FWA) Number assigned?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "in8.1.5",
"text": "Federal Wide Assurance Number (if assigned)",
"answer": [
{
"valueInteger": 56789
}
]
},
{
"linkId": "in8.1.6",
"text": "Reliance Status",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "APPROVED",
"display": "Approved for reliance"
}
}
]
}
]
},
{
"linkId": "in8.3",
"text": "Relying Site Principal Investigator",
"item": [
{
"linkId": "in8.3.1",
"text": "Relying Site Principal Investigator First Name",
"answer": [
{
"valueString": "Jane"
}
]
},
{
"linkId": "in8.3.2",
"text": "Relying Site Principal Investigator Last Name",
"answer": [
{
"valueString": "Doe"
}
]
},
{
"linkId": "in8.3.4",
"text": "Academic and Professional Degrees associated with the Relying Site Principal Investigator",
"answer": [
{
"valueString": "MD"
}
]
},
{
"linkId": "in8.3.10",
"text": "Department Name or Division",
"answer": [
{
"valueString": "Orthopedics"
}
]
},
{
"linkId": "in8.3.5",
"text": "Phone",
"answer": [
{
"valueString": "567-123-1234"
}
]
},
{
"linkId": "in8.3.6",
"text": "Email address",
"answer": [
{
"valueString": "drjanedoe@sampleuniversity.edu"
}
]
},
{
"linkId": "in8.3.7",
"text": "Address of Relying Site Principal Investigator",
"item": [
{
"linkId": "in8.3.7.1",
"text": "Street Address",
"answer": [
{
"valueString": "105 Sample University Ct."
}
]
},
{
"linkId": "in8.3.7.2",
"text": "City",
"answer": [
{
"valueString": "Sample City"
}
]
},
{
"linkId": "in8.3.7.3",
"text": "State",
"answer": [
{
"valueString": "NC"
}
]
},
{
"linkId": "in8.3.7.4",
"text": "Zip Code",
"answer": [
{
"valueString": "27612"
}
]
},
{
"linkId": "in8.3.7.5",
"text": "Country",
"answer": [
{
"valueString": "United States"
}
]
}
]
}
]
},
{
"linkId": "in8.9",
"text": "Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)",
"answer": [
{
"valueString": "Sample University Medical Center | | Jane Doe, MD | Sample City, NC"
}
]
},
{
"linkId": "in8.10",
"text": "Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)",
"answer": [
{
"valueString": "Jane Doe, MD"
}
]
}
]
},
{
"linkId": "in8",
"text": "Relying Site(s)",
"item": [
{
"linkId": "in8.5",
"text": "Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator",
"item": [
{
"linkId": "in8.5.1",
"text": "Is this relying site at the same institution as where the lead principal investigator is conducting the study?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "N",
"display": "No"
}
}
]
},
{
"linkId": "in8.5.3",
"text": "Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "N",
"display": "No"
}
}
]
},
{
"linkId": "in8.5.4",
"text": "Is this relying site also considered to be the lead site for the study?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "N",
"display": "No"
}
}
]
}
]
},
{
"linkId": "in8.1",
"text": "Relying Site Institution",
"item": [
{
"linkId": "in8.1.1",
"text": "Relying Institution Name",
"answer": [
{
"valueString": "Test Example University"
}
]
},
{
"linkId": "in8.1.3",
"text": "Relying Institution Phone",
"answer": [
{
"valueString": "6781233456"
}
]
},
{
"linkId": "in8.1.4",
"text": "Is a Federal Wide Assurance (FWA) Number assigned?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "in8.1.5",
"text": "Federal Wide Assurance Number (if assigned)",
"answer": [
{
"valueInteger": 34567
}
]
},
{
"linkId": "in8.1.6",
"text": "Reliance Status",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "POSSIBLE",
"display": "Potential/possible"
}
}
]
}
]
},
{
"linkId": "in8.3",
"text": "Relying Site Principal Investigator",
"item": [
{
"linkId": "in8.3.1",
"text": "Relying Site Principal Investigator First Name",
"answer": [
{
"valueString": "Xi-Yang"
}
]
},
{
"linkId": "in8.3.2",
"text": "Relying Site Principal Investigator Last Name",
"answer": [
{
"valueString": "Lee"
}
]
},
{
"linkId": "in8.3.3",
"text": "Relying Site Principal Investigator Suffix",
"answer": [
{
"valueString": "Jr."
}
]
},
{
"linkId": "in8.3.4",
"text": "Academic and Professional Degrees associated with the Relying Site Principal Investigator",
"answer": [
{
"valueString": "MD, PhD"
}
]
},
{
"linkId": "in8.3.5",
"text": "Phone",
"answer": [
{
"valueString": "6781233456"
}
]
},
{
"linkId": "in8.3.6",
"text": "Email address",
"answer": [
{
"valueString": "XiYangLee@teu.med.edu"
}
]
},
{
"linkId": "in8.3.7",
"text": "Address of Relying Site Principal Investigator",
"item": [
{
"linkId": "in8.3.7.1",
"text": "Street Address",
"answer": [
{
"valueString": "200 Test Example Circle"
}
]
},
{
"linkId": "in8.3.7.2",
"text": "City",
"answer": [
{
"valueString": "Example"
}
]
},
{
"linkId": "in8.3.7.3",
"text": "State",
"answer": [
{
"valueString": "MA"
}
]
},
{
"linkId": "in8.3.7.4",
"text": "Zip Code",
"answer": [
{
"valueString": "67890"
}
]
},
{
"linkId": "in8.3.7.5",
"text": "Country",
"answer": [
{
"valueString": "United States"
}
]
}
]
}
]
},
{
"linkId": "in8.9",
"text": "Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)",
"answer": [
{
"valueString": "Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA"
}
]
},
{
"linkId": "in8.10",
"text": "Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)",
"answer": [
{
"valueString": "Xi-Yang Lee, Jr., MD, PhD"
}
]
}
]
},
{
"linkId": "in8",
"text": "Relying Site(s)",
"item": [
{
"linkId": "in8.5",
"text": "Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator",
"item": [
{
"linkId": "in8.5.1",
"text": "Is this relying site at the same institution as where the lead principal investigator is conducting the study?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "N",
"display": "No"
}
}
]
},
{
"linkId": "in8.5.3",
"text": "Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "N",
"display": "No"
}
}
]
},
{
"linkId": "in8.5.4",
"text": "Is this relying site also considered to be the lead site for the study?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "N",
"display": "No"
}
}
]
}
]
},
{
"linkId": "in8.1",
"text": "Relying Site Institution",
"item": [
{
"linkId": "in8.1.1",
"text": "Relying Institution Name",
"answer": [
{
"valueString": "Central Campus Test University"
}
]
},
{
"linkId": "in8.1.4",
"text": "Is a Federal Wide Assurance (FWA) Number assigned?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "NI",
"display": "No Information"
}
}
]
},
{
"linkId": "in8.1.6",
"text": "Reliance Status",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "POSSIBLE",
"display": "Potential/possible"
}
}
]
}
]
},
{
"linkId": "in8.3",
"text": "Relying Site Principal Investigator",
"item": [
{
"linkId": "in8.3.1",
"text": "Relying Site Principal Investigator First Name",
"answer": [
{
"valueString": "Maria"
}
]
},
{
"linkId": "in8.3.2",
"text": "Relying Site Principal Investigator Last Name",
"answer": [
{
"valueString": "Smith"
}
]
},
{
"linkId": "in8.3.4",
"text": "Academic and Professional Degrees associated with the Relying Site Principal Investigator",
"answer": [
{
"valueString": "PhD"
}
]
},
{
"linkId": "in8.3.5",
"text": "Phone",
"answer": [
{
"valueString": "8901231234"
}
]
},
{
"linkId": "in8.3.6",
"text": "Email address",
"answer": [
{
"valueString": "maria.smith@CCTU.med.edu"
}
]
},
{
"linkId": "in8.3.7",
"text": "Address of Relying Site Principal Investigator",
"item": [
{
"linkId": "in8.3.7.1",
"text": "Street Address",
"answer": [
{
"valueString": "200 Central St."
}
]
},
{
"linkId": "in8.3.7.2",
"text": "City",
"answer": [
{
"valueString": "Central"
}
]
},
{
"linkId": "in8.3.7.3",
"text": "State",
"answer": [
{
"valueString": "MI"
}
]
},
{
"linkId": "in8.3.7.4",
"text": "Zip Code",
"answer": [
{
"valueString": "23456"
}
]
},
{
"linkId": "in8.3.7.5",
"text": "Country",
"answer": [
{
"valueString": "United States"
}
]
}
]
}
]
},
{
"linkId": "in8.9",
"text": "Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)",
"answer": [
{
"valueString": "Central Campus Test University | | Maria Smith, PhD | Central, MI"
}
]
},
{
"linkId": "in8.10",
"text": "Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)",
"answer": [
{
"valueString": "Maria Smith, PhD"
}
]
}
]
},
{
"linkId": "in9",
"text": "FDA exemption and IDE/IND Number",
"item": [
{
"linkId": "in9.1",
"text": "Does this study require a FDA exemption?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "in9.2",
"text": "Is an IND or IDE being used in this study?",
"answer": [
{
"valueCoding": {
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"code": "Y",
"display": "Yes"
}
}
]
},
{
"linkId": "in9.4",
"text": "Please select IND or IDE:",
"answer": [
{
"valueCoding": {
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"code": "IND",
"display": "IND"
}
}
]
},
{
"linkId": "in9.3",
"text": "IND/IDE Number",
"answer": [
{
"valueString": "432fdw512432fqsdf"
}
]
}
]
},
{
"linkId": "in10",
"text": "Questionnaire Version Details",
"item": [
{
"linkId": "in10.1",
"text": "Questionnaire Version",
"answer": [
{
"valueString": "2"
}
]
},
{
"linkId": "in10.2",
"text": "Questionnaire Version Date",
"answer": [
{
"valueDate": "2021-10-18"
}
]
}
]
},
{
"linkId": "ADMIN00",
"text": "Administrative Use Only (will be hidden in the future)",
"item": [
{
"linkId": "ADMIN01",
"text": "Link ID prefix",
"answer": [
{
"valueString": "in"
}
]
},
{
"linkId": "ADMIN02",
"text": "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any",
"answer": [
{
"valueString": "initiate-study-populate-exampleQR"
}
]
},
{
"linkId": "ADMIN03",
"text": "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses",
"answer": [
{
"valueString": "ResearchStudyExample-sIRB"
}
]
}
]
}
]
}