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Pandu ★ India, 2007-04-21 08:15 (7010 d 10:40 ago) Posting: # 681 Views: 4,756 |
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Dear All Please give me the information for DCGI Report Format and its Contents Regards, Pandu |
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Helmut ★★★   Vienna, Austria, 2007-04-21 11:33 (7010 d 07:22 ago) @ Pandu Posting: # 682 Views: 3,966 |
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Dear Pandu! Indian regulation states at section 3.1.12: The Sponsor should ensure the preparation and appropriate approval(s) of a comprehensive final clinical study report suitable for regulatory and / or marketing purposes, whether or not the study has been completed. All reports prepared should meet the standards of the GCP guidelines for Format and Content of Clinical Study Reports. The sponsor should also submit any safety updates and / or periodic reports as prescribed by the regulatory authorities. Consequently ICH (E3) 'Structure and Content of Clinical Study Reports' should apply. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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MGR ★ India, 2007-04-23 10:46 (7008 d 08:09 ago) @ Pandu Posting: # 686 Views: 3,921 |
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Dear Pandu, Please see the following link: http://cdsco.nic.in/html/BE%20Guidelines%20Draft%20Ver10%20March%2016,%2005.pdf I think this may helps u. And u look in page 26. You notice the contents. Regards, MGR Edit: Full quote removed. Please see this post! [HS] |
Ing. Helmut Schütz