EMA Reflection Paper on GCP for Trial Master Files, paper or electronic (draft), 12/12

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The European Medicines Agency (EMA) publishes “Reflection Papers” to communicate expectations to industry.

The purpose of this reflection paper is to set the requirements for Trial Master Files (TMF) and to give recommendations to assist organisations in maintaining a TMF that facilitates trial management, GCP compliance, and inspections.

See the following sections of Reflection Paper on GCP Compliance in Relation to Trial Master Files (paper and/or electronic) for Management, Audit and Inspection of Clinical Trials for electronic Trial Master File (eTMF) topics:

• Section 6 (Provision of Trial Master Files for Inspection) requires electronic Trial Master Files to be readily available to inspectors
• Section 7 (Electronic Trial Master Files) outlines requirements for eTMF content, controls, training, validation, security, backups, audit trails, electronic signatures.
• Section 8.7 (Electronic Archiving) outlines expectations for electronic archiving formats, backups, access, security, periodic testing, and migration to a new media
• Section 9 (Problems) lists issues that GCP inspectors have encountered when reviewing electronic Trial Master Files

This draft guidance was released for public comment in December, 2012. The comment period ended in 2013. In 2015 a note was added stating that feedback would be incorporated into a new TMF guidance.