Helmut ★★★ Vienna, Austria, 2017-05-23 16:12 (2527 d 20:44 ago) Posting: # 17395 Views: 5,626 |
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Dear all, today the EMA published the draft “Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol”. Interesting reading matter. End of consultation 22 August 2017. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
nobody nothing 2017-05-23 17:10 (2527 d 19:45 ago) @ Helmut Posting: # 17399 Views: 4,788 |
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Whistle blowing is an interesting concept, however, I guess in the US it only works when there are significant compensations for loosing your complete economic basis in your field of expertise. Am I wrong? PS: "3.1. Who should notify the serious breach? The sponsor or a person duly authorised by the sponsor to perform this function, if this function has been delegated by the sponsor to another party (for example, a legal representative or contract research organisation (CRO))" That's not how whistleblowing works, or? — Kindest regards, nobody |
Dr_Dan ★★ Germany, 2017-05-23 20:24 (2527 d 16:31 ago) @ nobody Posting: # 17403 Views: 4,823 |
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❝ 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 |
ElMaestro ★★★ Denmark, 2017-05-24 00:49 (2527 d 12:06 ago) @ Helmut Posting: # 17405 Views: 4,846 |
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Hi Hötzi and all, this isn't so much about whistleblowing. It is about defining a type of deviations that require expedited reporting (analogous to SAE's) and defining who is supposed to do what and when. It is already giving rise to some confusion. If we forget about fraud and cheating and misrepresentation, then there are certain types of situations that occur regularly and which could perhaps be considered to fall under these paragraphs. Examples include:
Just imagine an anaphylactic reaction occuring in such a study after the IMP was taken - on investigation it is concluded that it may or may not have occured due to impurity A or whatever. Regulators would surely murder the CRO for using the IMP in such cases, due to hindsight. — Pass or fail! ElMaestro |
Dr_Dan ★★ Germany, 2017-05-24 21:06 (2526 d 15:49 ago) @ ElMaestro Posting: # 17407 Views: 4,606 |
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❝ this isn't so much about whistleblowing. It is about defining a type of deviations that require expedited reporting (analogous to SAE's) and defining who is supposed to do what and when. IMHO the message of this guideline is fatal: EMA is not will to spent effort in the surveillance of clinical studies and has not the intellectual and personal capacities to do so. Why should the Sponsor provide the arguments which will be used to reject his study? The people who prepared this guideline live behind the moon. Dear car driver, report any contempt against red lights and tempo Limits to your authority so that your licence can be invalidated. hahaha — Kind regards and have a nice day Dr_Dan |
DavidManteigas ★ Portugal, 2017-05-25 14:37 (2525 d 22:18 ago) @ Dr_Dan Posting: # 17414 Views: 4,651 |
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Hi Dr. Dan, Not necessarily. If they don't report according to the guideline they could always be subject to an inspection and than have a "double finding". Also, regulators have access in their data to what is the "average" reporting of this kind of troubles, so they can even made inspections on a "risk-based" approach and under-reporting of findings would be one of the "triggers" for inspection. Regards, David |