This guidance is much more comprehensive for IRBs, investigators and sponsors than the current guidance document on the subject matter of continuing review from FDA.
This draft guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations.
The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review. When finalized, this document will supersede the Information Sheet, Continuing Review After Study Approval (September 1998, Office of Health Affairs, Food and Drug Administration).
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Dr. Riviera, graduate of Club Med School, is studying the effects of having only four fingers and a bright yellow complexion has on patient outcomes.
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The FDA has recently issued new rules that help clarify who is allowed to have access to investigational medications that are still in the testing phase.
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FDA Issues Draft Guidance on "IRB Contiinuing Review After Clinical Investigation Approval" This guidance is much more comprehensive for IRBs, investigators and sponsors than the current guidance document on the subject matter of continuing review from FDA.
Dr. Riviera, graduate of Club Med School, is studying the effects of having only four fingers and a bright yellow complexion has on patient outcomes.