Phlexglobal Issues Industry Advisory on New EMA Guidance


Applied Clinical Trials

Phlexglobal announced an important industry advisory around the new European Medicines Agency (EMA) guidance on Trial Master Files. The guidance took effect on June 6, 2019.

At 17 pages and going into specific detail, the new TMF guidance holds many potential pitfalls for companies, including:

  • Reinforces that from a regulatory perspective, the responsibility for an outsourced Trial Master File lies with the sponsor, and lays out numerous areas sponsors need to address – from the structure and indexing of the TMF to the details of eTMF system and change control management.

  • Details updated technology requirements for electronic TMF systems, including audit trails, access controls, backup, and archiving – and when other systems must also meet these requirements.

  • Explains why chapter 8 of GCP is not a definitive list of what should be in the Trial Master File – and the best place to get your checklist.

“Over the past 12-18 months, regulatory agencies have been increasing their focus around the Trial Master File and tightening their enforcement,” noted John McNeill CEO of Phlexglobal. “Where once inspectors might have let things go with a warning, today the consequences of poor TMF management include study delays or halts, as well as financial penalties. As a result, companies can no longer simply treat the Trial Master File as an afterthought.”

One reason for this increased stringency around the Trial Master File is a recognition among regulators that the TMF is an indicator for the study itself. This is spelled out clearly in the very first section of the guidance:

“Trial master file (TMF) plays a key role in the successful management of a trial by the investigator / institutions and sponsors. The essential documents and data records stored in the TMF enable the operational staff as well as monitors, auditors and inspectors to evaluate compliance with the protocol, the trial’s safe conduct and the quality of the data obtained.”

More information can be found at

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