SAP vs. part of the clinical protocol [General Sta­tis­tics]

posted by Helmut Homepage – Vienna, Austria, 2023-02-09 10:49 (882 d 13:54 ago) – Posting: # 23448
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Hi Sereng,

❝ 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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