QRTI Newsline --- Wednesday September 8, 2010

Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting - Improving Human Subject Protection

"This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems,including certain adverse events reports, to the Institutional Review Board (IRB) under Title 21 of the Code of Federal Regulations (21 CFR) part 56 (Institutional Review Boards), part 312 (Investigational New Drug Application), and part 812 (Investigational Device Exemptions). FDA developed this guidance in response to concerns raised by the IRB community, including concerns raised at a March 2005 public hearing, that increasingly large volumes of individual adverse event reports - often lacking in context and detail - are inhibiting rather than enhancing IRBs' ability to adequately protect human subjects. This guidance provides recommendations to sponsors and investigators for improving the quality of information they provide to IRBs."

"FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required."

The guidance can be found at: http://www.fda.gov/cber/gdlns/advreport.htm