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RegisterSAP vs. part of the clinical protocol [General Statistics]
posted by Helmut 
– Vienna, Austria, 2023-02-09 10:49 (613 d 21:27 ago) – Posting: # 23448
Views: 2,928
Hi Sereng,
Why not? Was accepted in 400 of my studies. Then I opted for a separate SAP.
What would you ordinarily expect?
No. However, whatever format is used (SAP or planned statistics as part of the clinical protocol) it must be detailed enough to enable assessors/inspectors to unambiguously reproduce results with given data.
❝ My CRO states that no "standalone" Statistical Analysis Plan (SAP) is required and that the statistical analysis in the protocol should suffice.
Why not? Was accepted in 400 of my studies. Then I opted for a separate SAP.
❝ However, the information in the protocol does not capture everything I would ordinarily expect to be in the SAP and I am not comfortable with the CRO's response.
What would you ordinarily expect?
❝ Is a (detailed) SAP required (or recommended), particularly where the entire NDA will be predicated on its findings?
No. However, whatever format is used (SAP or planned statistics as part of the clinical protocol) it must be detailed enough to enable assessors/inspectors to unambiguously reproduce results with given data.
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Helmut Schütz
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Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Are Statistical Analysis Plans “required” for Pivotal Studies? Sereng 2023-02-08 18:23 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- SAP vs. part of the clinical protocolHelmut 2023-02-09 09:49
- SAP vs. part of the clinical protocol Sereng 2023-02-10 23:34
- Traceability Helmut 2023-02-11 13:22
- SAP vs. part of the clinical protocol Sereng 2023-02-10 23:34
- Are Statistical Analysis Plans “required” for Pivotal Studies? Achievwin 2023-02-15 12:07
- Are Statistical Analysis Plans “required” for Pivotal Studies? ElMaestro 2023-02-16 06:55
- SAP vs. part of the clinical protocolHelmut 2023-02-09 09:49
Ing. Helmut Schütz