Eudralex Volume 10 Recommendation on the content of the trial master file and archiving

Title:
Eudralex Volume 10 Recommendation on the content of the trial master file and archiving

https://www.gmp-compliance.org/files/guidemgr/vol10 _chap5.pdf

Origin/Publisher:

European Commission - Enterprise and Industry Directorate General - Consumer goods - Pharmaceuticals

Content:
This guidance document provides further recommendation on ‘The Trial Master File and Archiving’, including relevant text from CPMP/ICH/135/955 – Note for guidance on Good Clinical Practice.

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