- Reviewing Amendments:Walks through the steps for completing reviews for amendments.
- Continuing Review: Touches on important considerations for the reviewer at the time of study renewal.
- Code of Federal Regulations 45 CFR 46 Basic HHS policy for protection of research subjects
*Please see the Reportable Events section of the IRB website for guidance documents regarding protocol deviations, potential noncompliance or unanticipated events, and related matters.
Additional FDA Guidance:
Tips for Successful Review:
Allow adequate time for review prior to meeting
Communicate with the facilitator and/or analysts regarding questions, concerns, or conflicts