Guidance for IRBs, Clinical Investigators and Sponsors

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In November 2012, The FDA published a new draft guideline, Guidance for IRBs, Clinical Investigators and Sponsors, to remind institutional review boards (IRBs) of their role in qualifying the clinical investigator, ensuring the adequacy of the clinical investigation site and determination of whether an IND or IDE is required for the proposed clinical investigation. As you know, there have been some major compliance issues noted by FDA relative to IRB oversight and involvement with clinical trials.

In the guidance document, FDA provides answers to the following questions:

  1. Must an IRB review the qualifications of clinical investigators who conduct FDA-regulated research?
  2. Is there any information publicly available from FDA about a clinical investigator’s inspectional history?
  3. Must an IRB review the adequacy of the research site?
  4. What are the IRB’s responsibilities with respect to verifying the determination of
  5. whether an IND or IDE is required for an FDA-regulated investigation?

Read the draft guideline here.