Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use United States of America flag

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, 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)