Re-consenting volunteers? [Off Topic]

posted by Ohlbe – France, 2016-06-22 07:06 (2836 d 12:15 ago) – Posting: # 16435
Views: 35,707

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 which had been replaced by a new Order in April 2014.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:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
79 visitors (0 registered, 79 guests [including 10 identified bots]).
Forum time: 18:21 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5