Prevention/Clinical Science Review Committee (P/CSRC) Frequently Asked Questions

Does my protocol/amendment have to be submitted for P/CSRC Review?

Your Medical Officer or Program Officer can advise you on the requirements for C/PSRC Review.

I know that my protocol/amendment has to be submitted for P/CSRC Review. To whom do I submit the documents?

These documents should be submitted to: Your Medical Officer or Program Officer, The DAIDS contact for PSRC or CSRC, CSIO@niaid.nih.gov and DAIDSRSC-CSRC@tech-res.com or DAIDSRSC-PSRC@tech-res.com

How do I receive an invitation to the teleconference for a P/CSRC Review?

Please contact your Medical Officer (or Program Officer if your protocol does not have a Medical Officer) or the DAIDS contact to whom you submitted the documents for P/CSRC Review.

The P/CSRC requested a response to its comments. Do I send this to RSC or DAIDS?

Your response should be sent to your Medical Officer (or Program Officer if your protocol does not have a Medical Officer). S/he will forward the response as appropriate.

FOR CSRC ONLY: My protocol/amendment already went through CSRC Review. Does my protocol/amendment have to be re-submitted for a second CSRC Review or for Final Approval?

Please communicate with your Medical Officer (or Program Officer if your protocol does not have a Medical Officer) to determine if your protocol/amendment needs to return for CSRC Review or Final Approval. The chart below indicates the possible actions following a Review but the determination as to whether or not your protocol/amendment must return for a second Review or for Final Approval rests with DAIDS and is not dictated by this chart.

CSRC Decision Do you have to return for a second CSRC Review? Do you have to return for CSRC Final Approval?
The CSRC recommends that the protocol team proceed with protocol/amendment development. Probably - confirm with Medical Officer Not applicable at this stage
The CSRC recommends that the protocol team proceed with protocol/amendment finalization. Probably not - confirm with Medical Officer Probably not - confirm with Medical Officer
Content last reviewed on 
February 9, 2018