How do I submit my Investigator’s Brochure (IB) update to the IRB?
Investigator’s Brochures are essential regulatory documents requiring IRB submission and review, but should these documents be submitted as a Modification or as Promptly Reportable Information (PRI)?
It depends…
IBs are reviewed annually and may be updated with Investigational Product (IP) information which does not identify or present new or increased risk than was previously known. This is often referred to as an administrative IB update. Administrative IB updates should be submitted to the IRB as a Modification, but do not need to be reported as PRI.
If an IB update includes a new or increased risk, this information should be reported as a study Modification and a PRI.
The PRI report in IRBIS includes targeted questions related to IB updates to facilitate the submission and review of these updates.
To address some of the Frequently Asked Questions (FAQs) related to how to submit IB updates to the IRB, please see the attached Investigator’s Brochure Update Flowchart and FAQs.
Please reach out to the OHRE Compliance team at IRB_Compliance@unc.edu for additional questions regarding IB updates.
If you have questions about the IRB or need any assistance with your submission, email the IRB at irb_questions@unc.edu.
To see past Did You Know posts, please follow this link: https://research.unc.edu/human-research-ethics/news/did-you-know/
To submit a topic or question for a future DYK, email Celeste Cantrell