Bioequivalence and Bioavailability Forum • Re-consenting volunteers?

Re-consenting volunteers? [Off Topic]

posted by Ohlbe – France, 2016-06-22 07:06 (3305 d 18:51 ago) – Posting: # 16435
Views: 40,711

Dear El Maestro,

❝ I am not a native French speaker but I think I sometimes understand a little bit of written French.

I am a native French speaker but there are a number of points in this report which I'm not getting either.

❝ Does the inquest into the Bial/Biotrial incident suggest that the volunteers should perhaps, possibly, maybe have been asked to re-confirm their consent after the initial SAE in their dosing group?

No, it does not suggest any such thing. It affirms it.

❝ Is there a French guideline or legal document specifically discussing re-consenting?

Not that I know of. Apart from the recent press releases of the Minister, of course :crying:

.

If you want to practice your French, have a look at Biotrial's response to the initial inspection report. A "lost for lost", last pleasure kind of thing. You'll see for instance that in their initial report the inspectors made reference to a ministerial Order of 2006 on the notification of SAEs... which had been replaced by a new Order in April 2014. This gives some idea on how well these guys know and understand our laws and regulations governing clinical trials.

—
Regards
Ohlbe

Complete thread:

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      - Chronology - English version Ohlbe 2016-01-29 18:30
        
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- Re-consenting volunteers? ElMaestro 2016-06-21 16:42
  - Re-consenting volunteers?Ohlbe 2016-06-22 05:06
    - Re-consenting volunteers? nobody 2016-06-22 11:26
      - Re-consenting volunteers? Ohlbe 2016-06-23 04:51
        
        Re-consenting volunteers? ElMaestro 2016-06-23 08:23
        
        Re-consenting volunteers? nobody 2016-06-23 10:36
        OT: strike d_labes 2016-06-23 11:31
        
        OT: strike Helmut 2016-06-23 13:01
- Paper in the NEJM Ohlbe 2016-11-03 12:21
- Death in phase I cannabinoid? nobody 2017-06-09 10:01