Trial Master Files are the collection of essential documents that are created and collected during a clinical trial. Sponsors and other clinical organizations use the trial master file to record how they have fulfilled their regulatory obligations for a clinical trial. The FDA as part of the Code of Federal Regulations (CFR) states in 21 CFR 312.50 that, “Sponsors are responsible for…ensuring that the investigations(s) is conducted in accordance with the general investigational plan and protocols contained in the Investigational New Drug (IND) Application”. In short, the TMF or eTMF is developed to serve and demonstrate that the clinical trial was undertaken compliantly.
While Trial Master Files have been in existence for 20 years this year, the best practice for the compilation of these essential documents has been widely discussed and debated as the regulations and technology have evolved. In today’s regulatory environment, these files are now required to be ‘audit ready’ at all times and specific documents may be requested at any point in time for inspection. With this shift towards greater governance and flexibility the state of Trial Master Files has been slowly moving towards the implementation of Electronic Trial Master File solutions like Montrium's, eTMF Connect.
Electronic Trial Master Files (eTMFs) now give sponsors and clinical trial stakeholders the ability to much more efficiently manage the documentation collected during clinical trials. Features such as remote access, electronic filing and key business intelligence allows life sciences organizations to increase efficiency and productivity while demonstrating compliance and making content available to inspectors much faster. TMF Europe, and independent Trial Master File events organization recently conducted their annual State of Trial Master Files survey, and produced a really interesting infographic with the results below.