The U.S. Food and Drug Administration has released draft guidance for clinical trial investigators outlining their safety reporting duties for investigational drugs and devices.
The draft, published on 29 September 2021, is focused exclusively on the role of investigators – not sponsors – and merges past final guidance from 2009 and 2012 on safety reporting that was previously mixed in with advice to sponsors. The prior guidance will remain in effect until the new document is finalized. FDA published separate draft guidance for sponsors earlier this year (RELATED: FDA releases new draft guidance on sponsor role for safety reporting requirements, Regulatory Focus 25 June 2021).
“Most of the information about the safety of a drug prior to marketing comes from clinical trials,” FDA wrote in the draft guidance. “Adverse event reports from investigators are therefore critically important, given that it is the investigators who observe subjects’ responses to an investigational drug.”
The draft guidance offers advice for clinical investigators on how to identify safety information that raises an “unanticipated problem involving risk to human subjects or others” for investigational drugs or “unanticipated adverse device effects” and how that information should be reported. It applies to investigational new drug application (IND) studies and investigational device exemption (IDE) studies…