What is the outcome of the RAC review?
The outcome of RAC review is a series of recommendations and advice from experts in the field. RAC review does not entail a formal approval of your proposed protocol. Investigators and sponsors should carefully consider these recommendations as part of optimizing the safe and ethical conduct of the trial. These recommendations will be captured in a summary letter prepared by OBA staff, which will be sent to you within 10 working days after completion of the RAC meeting. The summary letter also will be sent to the IRB and IBC reviewing your protocol, as well as the FDA.
