This guidance is intended to help clinical investigators comply with the following safety reporting requirements:
· Investigational new drug application (IND) studies under § 312.64(b) (21 CFR 312.64(b)
Investigational device exemption (IDE) studies under § 812.150 (21 CFR 812.150)
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) under § 312.66 (21 CFR 312.66)
2. For devices — Identify safety information that meets the requirements for reporting unanticipated adverse device effects (UADEs) to sponsors and IRBs under § 812.150(a)(1) (21 CFR 812.150(a)(1))
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.