Whistleblowers, stand up! [BE/BA News]

posted by Dr_Dan  – Germany, 2017-05-23 20:24 (2500 d 21:58 ago) – Posting: # 17403
Views: 4,745

❝ That's not how whistleblowing works, or? ;-)


"Serious breaches are notified through the EU CT system. All relevant fields must be completed"
No way to report anonymously, it's alway the sponsor (directly or indirectly). Paragraph 10.2 of a study Report according to CPMP/ICH/137/95 becomes obsolete. IMHO it is just a further administrative burden without gain in safety of subjects or reliability of data.

Kind regards and have a nice day
Dr_Dan

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