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 RSC or DAIDS?
- 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?
| 1. |
Does my protocol/amendment have to be submitted for P/CSRC Review? |
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Your Medical Officer or Program Officer can advise you on the requirements for C/PSRC Review. |
| 2. |
I know that my protocol/amendment has to be submitted for P/CSRC Review. To whom do I submit the documents? |
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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
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| 3. |
How do I receive an invitation to the teleconference for a P/CSRC Review? |
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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. |
| 4. |
The P/CSRC requested a response to its comments. Do I send this to RSC or DAIDS? |
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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. |
| 5. |
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? |
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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.
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CSRC Decision |
Do you have to return for a second CSRC Review? |
Do you have to return for CSRC Final Approval? |
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The CSRC recommends that the protocol team proceed with protocol/amendment development. |
Probably – confirm with Medical Officer |
Not applicable at this stage |
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The CSRC recommends that the protocol team proceed with protocol/amendment finalization. |
Probably not – confirm with Medical Officer |
Probably not – confirm with Medical Officer | |