DAIDS Regulatory Support Center - Frequently Asked Questions


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Prevention/Clinical Science Review Committee (P/CSRC)

Does my protocol/amendment have to be submitted for P/CSRC Review?
I know that my protocol/amendment has to be submitted for P/CSRC Review. To whom do I submit the documents?
How do I receive an invitation to the teleconference for a P/CSRC Review?
The P/CSRC requested a response to its comments. Do I send this to RCC or DAIDS?
FOR CSRC ONLY: My protocol/amendment already went through CSRC Review. Does my protocol/amendment have to return for CSRC Review or Final Approval?

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

Your Medical Officer or Program Officer can advise you as to 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. If you send your response to DAIDSRSC-CSRC@tech-res.com or DAIDSRSC-PSRC@tech-res.com, we will forward the response to your Medical/Program Officer and the P/CSRC Coordinator.

FOR CSRC ONLY: My protocol/amendment already went through CSRC Review. Does my protocol/amendment have to return for CSRC Review or 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 Review or Final Approval rests with DAIDS and is not dictated by this chart.

CSRC	CSRC Decision	Do you have to return for CSRC Review?	Do you have to return for CSRC Final Approval?
CSRC	The CSRC recommends that the protocol team proceed with protocol/amendment development.	Probably – confirm with Medical Officer	Not applicable at this stage
CSRC	The CSRC recommends that the protocol team proceed with protocol/amendment finalization.	Probably not – confirm with Medical Officer	Probably not – confirm with Medical Officer

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