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How Can You Streamline Reporting of SAEs
and IND Safety Reports?
While IRBs demonstrate several differences in their operations and reporting requirements, this article is to provide IntegReview IRBs reporting requirements related to SAEs, IND Safety Reports and Unanticipated Problems.
Per the FDA Guidance for 'Adverse Event Reporting to IRBs - Improving Human Subject Protection' dated January 2009:
The receipt of a large volume of individual AE reports without analysis of their significance to a clinical trial rarely supports an IRB's efforts to ensure human subject protection.
Per this Guidance, individual reports are not required to be submitted to the IRB. IntegReview IRB does not require the reporting of SAE or IND Safety Reports. FDA requires these be reported to the Sponsor, not to the IRB. FDA recommends that there be careful consideration of whether an SAE is an unanticipated problem that must be reported to the IRB.
IntegReview's definition of an Unanticipated Problem: any incident, experience, or outcome that meets all of the following criteria:
(1) Unexpected (in terms of nature, severity, or frequency);
(2) Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures in the research); and
(3) Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Despite this Guidance and IntegReview's policy, we continue to receive an abundance of SAE and IND Safety Reports that do not qualify as unanticipated problems. Our recommendation to Sponsors and to all others that write research protocols is to not include the IRB in the reporting of SAEs and INDs, but to only require they be reported to the Sponsor and we will continue to educate our Investigators and Sponsors on our reporting requirements.
The FDA's ultimate goal is to provide more meaningful information to IRBs, particularly when sponsor analysis (including an analysis of the significance of the adverse event, with a discussion of previous similar events where appropriate) is made available to IRBs.
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