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

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

15 June 2015
EMA/INS/GCP/636736/2012
Good Clinical Practice Inspectors Working Group (GCP IWG)
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