The studys sponsor has sent me an Investigators Brochure (IB) that I need the IRB to acknowledge. What do I need to include when I send it to the IRB office?
Retain a copy for your records then send a copy to the IRB office. Attach a brief cover letter with the WMC Principal Investigator’s name, protocol title and WMC protocol number. It is also important to identify in the cover letter whether or not any changes are necessary to the consent form or protocol. Also make sure you attach a sheet that outlines/details all of the changes in the new IB. If it did not come with the packet you received from them, call the sponsor and request it. The IB will be returned to you if all of the above is not present in one package. If a consent change is necessary, attach a highlighted consent form outlining what is to be changed. Attach a clean copy (non-highlighted) for stamping. You will receive an acknowledgement letter from the IRB office within 2-3 weeks of submission.
Related Questions
- What are the Investigators responsibilities related to study management of problems/events that will not meet Mayos IRB definition of UPIRTSO?
- May an IRB require that the sponsor of the study and/or the clinical investigator be identified on the studys consent document?
- Must an investigators brochure be included in the documentation when an IRB reviews an investigational drug study?
