Reflection paper on good-clinical-practice compliance in relation to trial master files (paper and / or electronic) for management, audit and inspection of clinical trials

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Download document Reflection paper on good-clinical-practice compliance in relation to trial master files (paper and / or electronic) for management, audit and inspection of clinical trials
Reference number EMA/INS/GCP/3636736/2012EMA/INS/GCP/636736/2012
Status draft: consultation closed
First published 18/02/2013
Last updated 18/02/2013

Summary

This reflection paper has been prepared to bring together the requirements of European Union (EU) legislation and guidance relating to the trial master file (TMF). This is deemed necessary by the EU Good Clinical Practice Inspectors Working Group inspectors due to the numerous questions asked by organisations in relation to the TMF (in particular electronic TMFs) and also to the repeated inspection findings concerning the TMF that have been made.