Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use

Single Institutional Review Board (sIRB) Implementation Guide, published by HL7 International - BR&R Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-sirb/ and changes regularly. See the Directory of published versions

## Example QuestionnaireResponse: Example Initiate a Study Questionnaire Response

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