- 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:
- Emory IRB Medical Device Guidance- New
- Emory IRB Decision chart for Devices used in Human Subject Research Studies- New
- Emory IRB Decision Chart for Drugs Used in Human Subject Research Studies- New
- FDA-CDER Chronicles: Drug, Not a drug, or More
- Dietary Supplements FAQ
- Dietary Supplements and/or Medical Foods Worksheet
- Expanded Access Use - Devices
- Expanded Access Use - Drugs
- Guidance for Emory Sponsor-Investigators
- HUD Patient Information Sheet
- Investigational Drugs and Devices
- Investigator Justification for IDE Exemption
- Investigator Justification for IND Exemption
- In Vitro Diagnostic Device Studies 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