Draft Guidance on Continuing IRB Review after Clinical Investigation Approval
This post was written by Paul Sheives.
A draft guidance was issued by FDA to help institutional review boards (IRBs) fulfill their continuing review responsibility under FDA regulations by providing guidance on the criteria, process, and frequency ofcontinuing IRB review necessary to ensure that subjects in clinical trials are protected. Although directed primarily at IRBs, the draft guidance should also assist sponsors and clinical investigators to fulfill their responsibilities related to continuing review. The FDA is seeking comments on the draft guidance by March 15, 2010 for consideration when drafting the final guidance.
