Earlier this week the Medicines and Healthcare products Regulatory Agency (MHRA) released The Good Clinical Practice Guide. The MHRA is the UK government agency responsible for ensuring the safety and efficacy of medical products, similar in function to branches of the US FDA. The guide is intended to “provide practical advice about implementing the principles of Good Clinical Practice within the context of the clinical trial regulatory framework in the European Union.”
The MHRA has been very forward thinking to provide guidance on clinical processes and technologies, and many clinical operations personnel are gratified to have additional insight into an agency’s perspective on GCP. For example, the MHRA has been very forthcoming with opinions on Trial Master File (TMF) requirements and appropriate use of eTMF systems; in the Guide, the MRHA has dedicated an entire chapter to Trial Master File and Archiving.
In contrast, the FDA CFR does not provide direct TMF guidance, and the guidance for FDA GCP inspections does not even contain a reference to TMF. The industry has been reliant on Section 8 of the ICH Guidance Document on Good Clinical Practice, which covers essential documents and when they are needed in a clinical trial.
It is especially welcome to have one agency’s perspective on the more tactical approaches to the use and management of the TMF. In the Guide the MHRA has addressed:
Should the TMF contain only essential documents?
Do we need to have signatures on all documents?
How should the TMF be managed/stored?
Can documents be destroyed after scanning?
How do I use eTMF with a CRO?
I enthusiastically welcome the insight from the MHRA, and am delighted to help my client’s understand the ramifications. This guidance and the industry discussions it will spark can only help to move forward mature electronic TMFs and encourage paper destruction initiatives. I hope it will stimulate the FDA and other agencies to create their own relevant guidance. Of course, companies must consult their internal Regulatory, Quality and Records functions before making changes, as local regulations and business process also dictate actual practice. This fall it’s anticipated that an inspector’s working group of the European Medicines Agency (EMA) will release a TMF position paper which I hope will continue the industry movement to robust eTMF adoption/use.
I will be closely reviewing this guidance in future posts and will be incorporating some of the ideas into future Trial Master File Maturity Model process.
What are your thoughts on the updated guidance report?
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Director Clinical Optimization Practice Life Sciences
James O'Keefe leads the Clinical Optimization Practice for Life Sciences Solutions. Mr. O'Keefe is responsible for piloting the practice's growth with capabilities that are centered on business consulting and process optimization. In this role, Mr. O'Keefe has focused on driving change and adoption of new business capabilities such as: Structured Protocol and Content Authoring; the transition to electronic management of Trial Master Files and Investigator Interactions; and optimizing Investigator Grants Management and Payments.
Formerly with a division of EMC Consulting, Mr. O'Keefe has over 15 years of business and IT consulting experience, with the past six years focused in the Clinical space of Life Sciences. His expertise includes enabling efficiencies in Clinical Site Monitoring, Protocol Optimization, and the implementation of electronic Trial Master Files and Clinical Investigator portals.
Mr. O'Keefe holds a BA in English Literature from Fordham University. He is an active member of the Drug Information Association, most recently sitting on the Document Management SIAC working group for Trial Master File Reference Model recommendations.