Did You Know? Investigator Brochure Updates (UNC OHRE)
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 … Read more