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RegisterDCGI Report Format [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2007-04-21 11:33 (7011 d 03:25 ago) – Posting: # 682
Views: 3,972
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.
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.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- DCGI Report Format Pandu 2007-04-21 06:15
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- DCGI Report FormatHelmut 2007-04-21 09:33
- DCGI Report Format MGR 2007-04-23 08:46
Ing. Helmut Schütz