On October 1, 2021 the UNC-Chapel Hill OHRE released the newest version of SOP 1401 – Promptly Reportable Information. This replaces SOP 1401 – New Safety Information and is in effect as of October 1, 2021. This revision was done to align definitions across collaborating institutions, comply with FDA requirements and recent guidance, and enhance readability.
This guidance encompasses the September 30, 2021 FDA draft guidance on Investigator Responsibilities for Safety Reporting on Drug and Device Studies. In preparation for this revision, we held a virtual session with the research community on Thursday, September 30 and the recording can be found on the OHRE website.
The OHRE will also be updating the PRI form in IRBIS and its website over the next several weeks and providing additional information as available.
Please reach out to the UNC Compliance team by emailing irb_compliance@unc.edu If you have questions about this SOP update.
Thanks,
John Roberts
Co-Interim Director
Associate Director, Regulatory Affairs & Compliance
Office of Human Research Ethics, UNC-CH
919-966-2748