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@tech-res.com 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 |