Forum Rules:
- Be courteous and respectful.
- Ask questions and discuss topics of interest.
- Share your knowledge and experiences.
- Create connections and a sense of community.
Hi all, I’m looking to learn more about how your institutions are addressing new contents of the December 2025 FDA “Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices”. There is a new statement that was not previously included in the 2012 version: “The investigator should review all IND safety reports received from sponsors as a part of the investigator’s responsibility to protect the rights, safety, and welfare of trial participants (see § 312.60).”
If your institution allows the investigator of an externally sponsored study to delegate review of INDSRs to another qualified member of the study team, and the PI only personally reviews those that meet the definition for UAP, how are you interpreting this new statement?
