Questions about data manipulation [GxP / QC / QA]

posted by Helmut Homepage – Vienna, Austria, 2024-04-30 13:46 (20 d 15:58 ago) – Posting: # 23968
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Hi QA,

❝ Is it advisable that CRO use this software (after implementing the SOP within the system) …

Yes, but…

❝ … and prove that no such manipulation was done during BE study.

Unfortunately you cannot prove that in the statistical sense (null hypothesis = no manipulation, alternative hypothesis = manipulation). The assessment contains still a subjective element. Sorry.

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