Conflict of Interest [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2013-09-24 16:49 (4663 d 03:31 ago) – Posting: # 11553
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Dear Santosh Tompe
Your Independent Ethics committee for review of protocol is registered and approved by DCG(I) and therefore you have to use this committee to get an approval for your study. If you could choose another Ethics committee you should do so in order to avoid any doubts. If a member of an Independent ethics committee is related to your Principal Investigator then this committee member should not take part in the discussion and approval of the studies submitted by his/her relative.
However, this case should be mentioned in your Independent Ethics committee's rules of procedure (see paragraphs 3.2.2 to 3.2.4 of the ICH-GCP guideline CPMP/ICH/135/95).
Kind regards
Dan

Kind regards and have a nice day
Dr_Dan

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