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sparsh ☆ India, 2013-09-24 14:50 (4656 d 01:03 ago) Posting: # 11548 Views: 3,233 |
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Dear Sir, I am working in a Pharmaceutical company and we have Independent Ethics committee for review of protocol which is recently registered and approved by DCG(I). We have a Principal Investigator at our clinical site and his one of the family member is the member of our Independent ethics committee. My question is that it may cause/ conflict of interest as per Indian regulation i.e. ICMR (Indian) guideline 2006. Hoping for your kind response at the earliest. Regards, Santosh Tompe |
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Dr_Dan ★★ Germany, 2013-09-24 16:49 (4655 d 23:04 ago) @ sparsh Posting: # 11553 Views: 2,739 |
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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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sparsh ☆ India, 2013-09-25 07:31 (4655 d 08:22 ago) (edited on 2013-09-25 10:05) @ Dr_Dan Posting: # 11555 Views: 2,622 |
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Ing. Helmut Schütz