P16: Best Practices: Keys Steps to Maintaining TMF Inspection-Readiness
Poster Presenter
Karen Roy
Chief Strategy Officer
Phlexglobal United Kingdom
Objectives
Review the most common reasons companies fail a Trial Master File inspection
Learn what inspectors are looking for during their TMF inspection
Examine proven ways to improve inspection-readiness in your organization & other organizations involved with the TMF such as sites and service providers
Method
Leading TMF practitioners and regulatory experts will review common causes of TMF inspection failure – such as incompleteness, poor quality control, and lack of sponsor oversight – and offer pragmatic guidelines for improving inspection-readiness.
Results
Regulatory agencies are increasingly viewing the Trial Master File (TMF) as a key indicator of study health and compliance with GCP. As a result, agencies have been increasing their scrutiny of the TMF, issuing updated guidance, and tightening enforcement.
Examples include:
In 2018, the US FDA released an addendum to ICH E6 (R2) which encompassed quality management responsibilities for trial sponsors. Included were several TMF-specific provisions around essential documents, certified copies, archiving, audit trails, and more.
In June 2019, new EMA guidance on Trial Master Files took effect, providing detailed guidelines for TMF compliance – such as the responsibilities of sponsors, CROs, and sites, and the technology requirements for eTMF systems.
The GCP inspections metrics report from the MHRA, published in May 2018, listed several critical and major inspection findings given to both sponsors and CROs related to poor-quality Trial Master Files.
Conclusion
Leading TMF practitioners and regulatory experts will review the most common causes of TMF inspection failure – such as incompleteness, poor quality control, and lack of sponsor oversight – and offer pragmatic guidelines for improving inspection-readiness, including:
What regulatory agencies are focusing on when they inspect a TMF.
How to evaluate the TMF structure and plan, together with related processes, to ensure a full understanding of the scope of the TMF across a sponsor organization, CROs, and investigator sites.
Proven ways to develop an inspection-readiness culture across functional areas, to improve for example the timely filing of essential documents.
How to leverage the comprehensive TMF plan that’s part of the TMF Reference Model (part of the DIA Document and Records Management Community).
The benefits of mock inspections in exposing deficiencies that can negatively impact TMF health, while providing justification for additional resources and management support to improve inspection-readiness.
