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Subject: Public review comments for etmf-v1.0-csprd01: 1 Introduction
Comment type [editorial | Impact [major | The text is not specific enough for an introduction to a global specification of this kind. The specification is specifically for content of the trial master file and NOT the “clinical trial domain”. The conduct of clinical trials creates numerous other data, documents and records – together with the systems that manage those data, documents and records - which are outside the scope of this specification. Eldin Rammell Principal Consultant, Rammell Consulting Ltd. |
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