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 ResearchStudy: Example of Research Study

Generated Narrative: ResearchStudy

Resource ResearchStudy "ResearchStudyExample-sIRB" Version "2" Updated "2021-07-28 19:08:33+0000"

identifier: The Questionnaire Response ID for the associated Initiate a Study FHIR Questionnaire Response: initiate-study-populate-exampleQR (use: USUAL), IRB Study Protocol Number assigned by the research study management database of the lead institution: PRO098765 (use: USUAL)

title: A clinical study of the efficacy of Drug A for arthritis

protocol:

> identifier: id: PRO098765 (use: USUAL)

> name: PlanDefInitiateStudyPopulateExampleQR

> status: draft

status: in-review

category: Interventional Study (ncimeta.nci.nih.gov#C98388)

keyword: Gov-123456 (www.protocols.examplenationalgovernmentfunder.org#Gov-123456)

principalInvestigator:

> name: Jane Doe, MD(OFFICIAL)

> Generated Narrative: PlanDefinition #plandefinition-initiate-study-populate-exampleQR

> identifier: id: PRO098765 (use: USUAL)

> name: PlanDefInitiateStudyPopulateExampleQR

> status: draft

> Generated Narrative: Practitioner #practitioner-initiate-study-populate-exampleQR

> name: Jane Doe, MD(OFFICIAL)