Bioequivalence and Bioavailability Forum • Re-consenting volunteers?

Re-consenting volunteers? [Off Topic]

posted by Ohlbe – France, 2016-06-22 07:06 (2857 d 11:53 ago) – Posting: # 16435
Views: 35,885

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 which had been replaced by a new Order in April 2014.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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      - Protocol ElMaestro 2016-01-28 15:07
        
        Protocol nobody 2016-01-28 15:40
        
        FIM / FIH Helmut 2016-01-28 17:10
        
        FIM / FIH nobody 2016-01-28 17:55
        
        There is something rotten in the state... nobody 2016-02-26 21:05
        
        Rotten or not rotten ? Ohlbe 2016-02-27 05:49
        
        Rotten or not rotten ? nobody 2016-02-27 10:56
        
        Rotten or not rotten ? Ohlbe 2016-02-27 14:00
        
        Rotten.. nobody 2016-04-25 17:21
        
        Blame game... nobody 2016-05-23 12:27
        
        FDA: "unique toxiciy" nobody 2016-08-15 16:38
      - Chronology - English version Ohlbe 2016-01-29 18:30
        
        Chronology - English version Helmut 2016-01-29 19:04
        
        Administrative inspection preliminary outcome Ohlbe 2016-02-04 23:30
- 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