Since the issuance of the FDA Guidance, "Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs -Improving Human Subject Protection" in January 2009, I have noticed that more and more IRBs seem to be interpreting this guidance to mean that they don't need to require Principal Investigators to submit all IND Safety Reports for their review. This is not what the guidance allows. I am just wondering if anyone else is seeing this or has any comments on it.
Karen Hopkins, RN, BS, MS
Acting Director, GCP Operations
ClinAudits, LLC
Tuesday, September 29, 2009
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