Phlexglobal Issues Industry Advisory on New EMA Trial Master File Guidance

Comprehensive guidance took effect June 6, 2019; will significantly impact sponsor and CRO compliances

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Amersham, UK; Malvern, PA. June 20, 2019 — Phlexglobal today 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, and promises to have far-reaching impacts on an organization’s TMF processes, technology, and best practices – as well as related departments and systems.

At 17 pages and going into specific detail – unusual for most guidance documents – 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.”

“Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic),” Section 1, page 3

Based on extensive experience helping organizations successfully pass hundreds of regulatory inspections, Phlexglobal’s TMF and regulatory experts have compiled a detailed analysis of the new TMF guidance. Available from the Phlexglobal website, the document – “10 Things You Should Know About the New TMF Regulatory Guidance” – lists those areas most likely to cause compliance challenges for both sponsors and CROs, and provides pragmatic advice on what to watch for.

“The good news is that the new EMA guidance forms the most detailed guide to TMF best practices yet published by a regulatory agency, and in fact is becoming a de facto industry standard,” observed Eldin Rammell, Director of Expert Solutions at Phlexglobal. “As the authority in Trial Master File best practices, we’ve been actively helping our customers worldwide raise their TMF standards.”

Phlexglobal experts will be available at booth 2136 at the DIA Annual Meeting in San Diego to answer questions about the new TMF guidance. Visit to schedule a free consultation.

About Phlexglobal

Phlexglobal are world renowned thought leaders and specialists in the provision of electronic Trial Master File (eTMF) systems and services. They offer a unique combination of eTMF technology with PhlexTMF – their market leading eTMF system, quality services and specialist resource that delivers a range of flexible, targeted solutions to meet your business needs. Phlexglobal is headquartered in the UK, with offices in Malvern, PA and Lublin, Poland.

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