Questions about data manipulation [GxP / QC / QA]

posted by mittyri – Russia, 2023-07-22 21:57 (129 d 09:20 ago) – Posting: # 23682
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Dear Ohlbe, Dear Helmut,

❝ According to the referral notification there were, again, duplicated subjects in over 20 different studies.


Could you please elaborate how is it possible?
What is the method CRO used for duplication? just copy all concentration points to another subject? what about chromatograms? Did they fake date/time of that?

Why experts didn't find it before? Are the methods of data manipulation recognition just implemented?

Kind regards,
Mittyri

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