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Human Subjects Division (HSD)

Regulatory Updates

FDA: Final Guidance for Clinical Investigators, Sponsors and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection

Feb 2, 2011 at 9:31am

The link to the guidance document Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs - Improving Human Subject Protection has been updated from the draft guidance document to the final guidance document.

This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems including certain adverse events reports, to the institutional review board (IRB) under Title 21 of the Code of Federal Regulations (21 CFR) part 56 (Institutional Review Boards), part 312 (Investigational New Drug Application), and part 812 (Investigational Device Exemptions). Specifically, the guidance provides recommendations for sponsors and investigators conducting investigational new drug (IND) trials to help them differentiate between those adverse events that are unanticipated problems that must be reported to an IRB and those that are not. The guidance also makes suggestions about how to make communicating adverse events information to IRBs more efficient.

See: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126572.pdf