Bioequivalence and Bioavailability Forum • Whistleblowers, stand up!

Whistleblowers, stand up! [BE/BA News]

posted by Dr_Dan – Germany, 2017-05-23 20:24 (3312 d 17:04 ago) – Posting: # 17403
Views: 7,242

❝ 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

Complete thread:

Whistleblowers, stand up! Helmut 2017-05-23 14:12
- Whistleblowers, stand up! nobody 2017-05-23 15:10
  - Whistleblowers, stand up!Dr_Dan 2017-05-23 18:24
- This isn't about whistleblowers ElMaestro 2017-05-23 22:49
  - This isn't about whistleblowers Dr_Dan 2017-05-24 19:06
    - This isn't about whistleblowers DavidManteigas 2017-05-25 12:37