IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
August 27, 2013
July 22, 2021
797294db-f9b3-4c0d-b100-f6ee4b81ebae
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