Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . 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 Downloads
...4 Artifacts Summary
....4.1 Initiate a Study Questionnaire
....4.2 Protocol Questionnaire
....4.3 Consent Questionnaire
....4.4 Recruitment Materials Questionnaire
....4.5 Determination Letter Questionnaire
....4.6 Continuing Review Questionnaire
....4.7 Adverse Medical Event Questionnaire
....4.8 Adverse Non-Medical Event Questionnaire
....4.9 Adverse Non-Medical Event Questionnaire Response
....4.10 Protocol Questionnaire Response
....4.11 Adverse Medical Event Questionnaire Response
....4.12 Initiate a Study Questionnaire Response
....4.13 Determination Letter Questionnaire Response
....4.14 Recruit Questionnaire Response
....4.15 Continuing Review Questionnaire Response
....4.16 Consent QR
....4.17 Example of Research Study
....4.18 Determination Questionnaire with pre-population
....4.19 Temporary Codes