Question:

For a non-interventional registry, is it appropriate/acceptable to submit an updated protocol to IRB before submitting to FDA? The changes made were not requested by the FDA.
– Senior Project Director, CRO

Response:

It is acceptable to submit an updated protocol to the IRB prior to submitting to the FDA. However, it is important to note that the change in the study cannot be implemented until both groups have provided approval of the changes. Which means if the updated protocol is sent to the IRB prior to FDA review, and the FDA requires changes before implementation, an additional submission will be required to the IRB prior to the change being implemented.