The EMA Draft Guideline On A GCP Compliant Trial Master File

The European Medicines Agency recently published a draft guideline titled “Good Clinical Practices (GCP) compliance in reaction to Trial Master Files (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials.”

Most of this guidance has been derived from the revised version of the reflection paper on TMF and includes detailed descriptions of content, management, archiving, audit, and inspection of clinical trials along with the latest ICH E6 revision. This guidance is still a draft for consultation, and they are accepting comments until July 11, 2017.