Re-consenting volunteers? [Off Topic]

posted by Ohlbe – France, 2016-06-23 06:51 (2836 d 10:07 ago) – Posting: # 16447
Views: 35,775

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

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