I received an Action Letter/CAEPR or a revised IDB from the Sponsor. Does this need to be reported to the IRB?
Frequently Asked Questions Revised November 2012
Researchers are expected to report new information with the potential to affect the risks, benefits, or alternatives to study participation to the IRB within 14 business days of receipt. This new information can be provided to the study team via several different mechanisms; sometimes the new information is received multiple times. For example, the Sponsor will release an Action Letter containing new risk information, and also state that a protocol amendment will be forthcoming.
Action Letters/CAEPRs will generally precede the submission of a change of protocol. In these cases, a new information report should be submitted to the IRB if the amended study documents will not be received within 14 days of receipt of the new information (i.e., action letter, revised CAEPR).
However, if the study team knows they will be receiving the accompanying change of protocol (i.e., revised study documents) within 14 business days of receiving the action letter or revised CAEPR it is NOT necessary to submit a new information report. The study team should instead submit the change of protocol (which should include the action letter or revised CAEPR as well as amended study documents) within 60 days of receipt of the new information document.
IDBs: How to submit a revised IDB to the IRB depends on whether or not the IDB contains new information that affects the risk/benefit ratio of the study. For details on when to submit revised IDBs, see Guidance for the Submission of Investigator's Drug Brochures (IDBs) and Package Inserts .