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 Determination Letter Questionnaire Response

LinkId | Text | Definition | Answer
--- | --- | --- | ---
determination-populate-exampleQR |  | QuestionnaireResponse |
dl1 | Research Study |  |
dl1.1 | Study Title |  | Study of Drug A for arthritis
dl1.2 | IRB Protocol Number |  | PRO098765
dl2 | Reliance Determination |  |
dl2.1 | sIRB (Reviewing Institution) |  |
dl2.1.1 | Institution |  |
dl2.1.1.1 | sIRB (Reviewing Institution) Name |  | X Pharmaceutical Research IRB
dl2.1.1.2 | Federal Wide Assurance (FWA) |  | 12345
dl2.2 | Determination Decision |  | Temporary Codes AR: Accepts Review
dl5 | Lead Principal Investigator Responsible for Overall Study |  |
dl5.1 | First Name |  | Jane
dl5.2 | Last Name |  | Doe
dl5.5 | Degree(s) |  | MD
dl5.3 | Email |  | drjanedoe@sampleuniversity.edu
dl11 | Lead Principal Investigator Institution |  |
dl11.1 | Lead Principal Investigator Institution Name |  | Sample University Medical Center
dl7 | Relying IRB |  |
dl7.5 | Relying institution and Relying Site Principal Investigator for this Determination Letter |  |
ExternalDataFor_dl7.5.1 | External Data For linkId dl7.5.1 |  |
dl7.5.1 | Select the relying site in order to pre-populate the relying institution and relying site principal investigator details below. |  | [not stated] : Test Example University | | Xi-Yang Lee, Jr., MD, PhD | Example, MA
dl7.1 | Relying Institution |  |
dl7.1.1 | Name |  | Test Example University
dl7.1.2 | Federal Wide Assurance (FWA) |  | 34567
dl7.2 | Relying Site Principal Investigator |  |
dl7.2.1 | First Name |  | Xi-Yang
dl7.2.2 | Last Name |  | Lee
dl7.2.4 | Suffix |  | Jr.
dl7.2.5 | Professional Degree(s) |  | MD, PhD
dl7.2.3 | Email |  | XiYangLee@teu.med.edu
dl9 | Point of Contact for Study Participants |  |
dl9.1 | First Name |  | Xi-Yang
dl9.2 | Last Name |  | Lee
dl9.4 | Suffix |  | Jr.
dl9.5 | Professional Degree(s) |  | MD, PhD
dl9.3 | Email |  | XiYangLee@teu.med.edu
ADMIN00 | Administrative Use Only |  |
ADMIN01 | Link ID prefix |  | dl
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, if any |  | ResearchStudyExample-sIRB
Documentation for this format