Re-consenting volunteers? [Off Topic]

posted by Ohlbe – France, 2016-06-23 06:51 (3154 d 18:27 ago) – Posting: # 16447
Views: 37,959

Dear Nobody,

❝ ❝ This gives some idea on how well these guys know and understand our laws and regulations governing clinical trials.


❝ ...if you outsource, you outsource, I don't think that the sponsor can be aware of all local regulations, the CRO should provide the sponsor in the protocol with all his obligations according to local laws. My opinion!


"These guys" in my sentence above did not refer to either the sponsor or Biotrial, but to the IGAS inspectors who perpetrated this report.

Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
23,379 posts in 4,913 threads, 1,661 registered users;
248 visitors (0 registered, 248 guests [including 23 identified bots]).
Forum time: 00:18 CET (Europe/Vienna)

Science is what you know.
Philosophy is what you don’t know.    Bertrand Russell

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