Draft Guidance for Clinical Investigators, Sponsors, and Investigational Review Board on Adverse Event Reporting—Improving Human Subject Protection

Announced the availability of a draft guidance titled "Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting—Improving Human Subject Protection" to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the Institutional Review Board