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

posted by Sereng  – USA, 2023-02-11 00:34 (117 d 10:12 ago) – Posting: # 23454
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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

❝ […] 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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