The U.S. Food and Drug Administration has released draft guidance for clinical trial investigators outlining their safety reporting duties for investigational drugs and devices.
This guidance is intended to help clinical investigators comply with the following safety reporting requirements:
• Investigational new drug application (IND)
• Investigational device exemption (IDE) studies
Recommendations are provided to help investigators identify the following:
1. For drugs — Identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting to institutional review boards (IRBs)
2. For devices — Identify safety information that meets the requirements for reporting 31 unanticipated adverse device effects (UADEs) to sponsors and IRBs
This document incorporates concepts pertaining to investigator responsibilities for adverse event reporting described in the guidance for industry and investigators Safety Reporting Requirements for INDs and BA/BE Studies (December 2012) (the 2012 final guidance) and in the guidance for clinical investigators, sponsors, and IRBs Adverse Event Reporting to IRBs—Improving Human Subject Protection (January 2009) (the 2009 procedural final guidance).
When finalized, this guidance will supersede corresponding sections in the 2012 final guidance and the 2009 procedural final guidance.
Until that time, however, the 2012 final guidance and the 2009 procedural final guidance continue to represent FDA’s current thinking on investigator responsibilities for safety reporting for investigational medical products.