New Art. 31 referral: suspected data manipulation again [GxP / QC / QA]

posted by Ohlbe – France, 2020-02-28 15:23 (2288 d 05:05 ago) – Posting: # 21189
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Dear all,

A new Article 31 referral has been announced on the EMA web site. It looks like another CRO has been caught manipulating data to make a failing study pass. More details in the referral notification.

Regards
Ohlbe

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