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

Table of Contents

...0 Table of Contents
...1 Single IRB (sIRB)
...2 Conformance and Functionality Expectations
...3 Additional Implementation Requirements and Considerations
...4 Descriptions of CodeSystems
...5 Workflow Diagrams
...6 Other
...7 Downloads
....8 Artifacts Summary
....8.1 Initiate a Study Questionnaire
....8.2 Protocol Questionnaire
....8.3 Consent Form Questionnaire
....8.4 Recruitment Materials Questionnaire
....8.5 Determination Letter Questionnaire
....8.6 Continuing Review Questionnaire
....8.7 Adverse Medical Event Questionnaire
....8.8 Adverse Non-Medical Event Questionnaire
....8.9 Example Adverse Non-Medical Event Questionnaire Response
....8.10 Example Protocol Questionnaire Response
....8.11 Example Adverse Medical Event Questionnaire Response
....8.12 Example Initiate a Study Questionnaire Response
....8.13 Example Determination Letter Questionnaire Response
....8.14 Example Recruitment Materials Questionnaire Response
....8.15 Example Continuing Review Questionnaire Response
....8.16 Example Consent Form Questionnaire Response
....8.17 Example of Research Study
....8.18 Temporary Codes
....8.19 sIRB Client Capability Statement
....8.20 sIRB Server Capability Statement