FDA draft covers adverse event reports to IRBs

April 16, 2007

The FDA announced the availability of a draft guidance designed to assist the research community in interpreting requirements for submitting reports of unanticipated problems such as certain adverse events reports to Institutional Review Board (IRB).

The FDA announced the availability of a draft guidance designed to assist the research community in interpreting requirements for submitting reports of unanticipated problems such as certain adverse events reports to Institutional Review Board (IRB). The agency developed the draft guidance in response to concerns raised by the IRB community that large volumes of individual adverse event reports are increasingly inhibiting rather than enhancing IRBs? ability to adequately protect human subjects. The guidance provides recommendations to IRB sponsors and investigators on how to improve the usefulness of the adverse event information submitted to IRBs.

 

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