Helmut
★★★
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Vienna, Austria,
2017-05-23 16:12
(2500 d 22:16 ago)

Posting: # 17395
Views: 5,524
 

 Whistleblowers, stand up! [BE/BA News]

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.

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2017-05-23 17:10
(2500 d 21:18 ago)

@ Helmut
Posting: # 17399
Views: 4,710
 

 Whistleblowers, stand up!

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
(2500 d 18:04 ago)

@ nobody
Posting: # 17403
Views: 4,744
 

 Whistleblowers, stand up!

❝ 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
(2500 d 13:39 ago)

@ Helmut
Posting: # 17405
Views: 4,767
 

 This isn't about whistleblowers

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:
  1. Someone forgot to activate the audit trail on an LC-MS/MS system. Needs reporting?
  2. Someone used pippettes (e.g. for QC production) whose calibration interval had expired. 5 days ago, 5 weeks ago, 5 months ago. It happened 4x the past 15 months and went unnoticed by monitors. Needs reporting?
  3. An injectable IMP arrives without a temperature logger, storage condition is "store in a cool dry place", the box was shipped 3 days ago from Ankara and has been sitting 44 hours at Dubai airport at unknown conditions in August. CRO asks the sponsor if there is a problem, the sponsor responds back there isn't without argumentation. Needs reporting? If yes, by whom?
IMP example 4 in the guideline draft is quite hopeless, by the way: "The IMP was stable" - and how exactly would a CRO or Sponsor know about that in any real-life situation in a way that would be defensible in case of regulatory questions? There is often a reason why an IMP is assigned an expiry of X months and not X+Y months. "Yes, we did study the IMP stability for 24 months, but we are only asking for 12 months on the SPC.", explained Arthur J. Scrotum from Goof Pharma to the regulator and added "and believe I saw Elvis yesterday."
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
(2499 d 17:22 ago)

@ ElMaestro
Posting: # 17407
Views: 4,528
 

 This isn't about whistleblowers

❝ 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
(2498 d 23:51 ago)

@ Dr_Dan
Posting: # 17414
Views: 4,573
 

 This isn't about whistleblowers

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
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