What forms are needed with a modification to the consent form or protocol, is a memo needed?
All study modifications must be summarized and reported to the IRB using IRB Form 8a. This form should accompany the complete revised version of the modified document (e.g. revised protocol, revised consent form, etc.) with an explanation, written by the PI, of the modification and its impact on the risk/benefit assessment. Include any supporting documentation from the sponsor or collaborators as appropriate. The explanation can be in the form of a memo. Click here for further guidance.
