Clinical trials documentation amendments

EC Amendment on 2001/83/EC. Part 1, 5.2.C defines holding period of essential clinical trials document... 

During the course of its conduct, the sponsor may need to amend a clinical trial, as a consequence of the emergence of new information. If the amendments are deemed to be substantial, in that they may impact on the safety of trial subjects, or change the interpretation of the scientific documents in support of the conduct of the trial, or are otherwise significant, the sponsor shall notify the Competent Authority and the Ethics Committee, using a Trial Amendment Form. The Ethics Committee are permitted 35 days to approve the amendment. 

European Commission. Detailed guidance on the European clinical trials database (EuDRACT Database). April 2003, and successor documents CT 5.1 Amendment describing the development of EUDRACT-Lot 1 (May 1, 2004) and CT 5.2 EUDRACT core dataset. 

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