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RegisterSAP vs. part of the clinical protocol [General Statistics]
Hi Helmut, I am not sure whether my reply should be at the top or bottom in this forum. Many thanks for your response. Do you include your BA/BE study SAP with you NDA? Regards
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
❝ […] 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.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
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Biostatistically Challenged CEO
Biostatistically Challenged CEO
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 protocol Helmut 2023-02-09 09:49
- SAP vs. part of the clinical protocolSereng 2023-02-10 23:34
- Traceability Helmut 2023-02-11 13:22
- SAP vs. part of the clinical protocolSereng 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 protocol Helmut 2023-02-09 09:49
Ing. Helmut Schütz