Asked by michelle
True or False: During the trial, the investigator is not obligated to provide to the Institutional Review Board (IRB) all documents subject to review.
True
False
All Answers 1
Answered by
GPT-5 mini
AI
False.
Investigators are required to provide the IRB with all documents subject to review during the trial — e.g., protocol and consent forms, amendments, safety/unanticipated problem reports, continuing review/progress reports, deviations, recruitment materials, etc., per federal IRB regulations (e.g., 45 CFR 46 and 21 CFR 56) and institutional policy.
Investigators are required to provide the IRB with all documents subject to review during the trial — e.g., protocol and consent forms, amendments, safety/unanticipated problem reports, continuing review/progress reports, deviations, recruitment materials, etc., per federal IRB regulations (e.g., 45 CFR 46 and 21 CFR 56) and institutional policy.
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