Final Guidance on Investigator Responsibilities

In case you missed it, here are some key points for the other Final Guidance on investigator safety reporting responsibilities issued by the FDA in December. This guidance replaced Guidances Safety Reporting Requirements for IND and BA/BE Studies (Dec2012) and Adverse Event Reporting to IRBs – Improving Human Subject Protection (Jan2009).- Investigators must report SAEs to the Sponsor immediately (generally should not exceed one (1) calendar day)- Investigators must review all IND Safety Reports sent by the Sponsor. FDA considers this review critical for the investigator to protect the rights, safety and welfare of the investigator’s participants.- Investigators must report all unanticipated problems to IRBs. FDA is clear in this guidance that IND Safety Reports must be submitted to the IRB. Other site-level unanticipated problems that may require IRB reporting are also explained.- Addresses unanticipated adverse device effect (UADE) reporting and that these must be reported in parallel to both the Sponsor and IRB no later than 10 working days of learning of the effect. The investigator must also provide progress reports to the Sponsor, monitor and IRB no less than annually.

Investigator Responsibilities – Safety Reporting for Investigational D

fda.gov