EMA Unveils Revised Final Guideline on Clinical Trial Master File

Regulatory NewsRegulatory News | 18 December 2018 |  By 

Following the end of a consultation from the summer of 2017, the EMA’s Good Clinical Practice (GCP) Inspectors Working Group has adopted a final revised guideline on the content, management and archiving of the clinical trial master file (TMF).

The guideline, which is meant to help sponsors comply with European legislation and the ICH E6 guideline on GCP, is important because the TMF includes the essential documents and data records to enable operational staff as well as monitors, auditors and inspectors to evaluate compliance with a clinical trial protocol, the trial’s safe conduct and the quality of the data obtained.

The guideline discusses what a TMF should be composed of and how certain documents should be held separate by either the sponsor of the trial or the investigator/institution running the trial. Contract research organizations and other third parties also have other assigned duties, and the guideline spells out part of how those relationships should be established.

As far as the TMF contents, the guideline spells out what should be considered essential documents, including statistics and data management documentation, superseded documents, correspondence and the contemporariness of the TMF.

In terms of security and control of the TMF, the guideline also explains how access to the TMF should be managed, how storage areas should be appropriate and how electronic TMFs should ensure that the loss, alteration or corruption of data and documents does not occur.

The guideline also discusses the scanning and transfers of the TMF to other media, noting, “The ICH GCP guideline requires that copies (irrespective of the media used) in the eTMF that irreversibly replace originals should be certified copies of the original.”

As far as archiving, the guideline adds: “The TMF including the audit trail (for eTMF) should be archived appropriately to enable supervision after the clinical trial has ended.”

The guideline is expected to come into effect in six months.

Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)


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