Will there still be leadership review?
No, protocols will no longer be referred for leadership review under the new system.
My protocol or concept was already reviewed at the CCR concept review. Do I need to resubmit to this new committee?
No. However, as that protocol started review in the old system, it will need to stay there and be reviewed by the branch. For just these protocols, the old system will need to be followed for branch review (CCR reviewers in attendance, minute taker there to take minutes, etc.).
If you would prefer the new committee review the protocol, rather than the branch, you can send the protocol to the new committee.
My protocol was referred for leadership review at the CCR review. Do I still have to have leadership review or what type of review is needed at this point?
If your study was referred for leadership review, then you can choose to either send your protocol to the new committee for review or send forward for leadership review. But one of the two must occur.
How will the resource review determinations be communicated back to the PIs?
The investigators and branch chiefs will receive a separate communication regarding the resource review from the Clinical Advisory Group (CAG). Both this communication and the SR approval letter must be received in order to move forward to IRB submission.
Can concepts be submitted for review or is a full protocol required for submission?
If you are submitting the protocol to CTEP for review, you may submit the completed CTEP LOI form to the SRC in lieu of a completed protocol document. Otherwise, a full protocol must be submitted.
Does the protocol or protocol amendment need to be formatted/reviewed by the PSO prior to submission to the SR committee?
Not at this time. The PI may certainly choose to have this done prior to SR submission. If this review does not happen prior to SR submission, then it will need to take place prior to IRB submission. To prevent avoidable stipulations, it is strongly recommended that QC occur prior to submission.
My protocol is being reviewed at the meeting. How will I be notified when the committee wants to talk to me?
When the meeting agenda is set, you will be notified of a time slot to arrive in and meet with the committee.
Is there a maximum number of protocols/amendments that can be reviewed at a single meeting?
This will be up to the person chairing each meeting.
Note: If you have a scientific review question that isn’t answered here, please contact: email@example.com