Another domain of Clinical Research is in trend with the current development phases. EMA created a draft guideline document that recognizes the importance &legal equivalence of the TMF and the eTMF, and provided guidance to organizations implementing TMFs & eTMF systems. In the guideline document, EMA inspectors stated that paper TMF documents may be stored in electronic eTMF systems.
Trial Master File refers to a repository of documents that collectively can be used by monitors, auditors, assessors and sponsors to demonstrate that a clinical trial has been conducted in compliance with Good Clinical Practice (GCP) and the approved protocol. TMF is a requirement under GCP, and a list of Essential Documents that should be available before the clinical phase of the study starts, those that should be collected / added during the conduct of the study, and finally those that must be collected after completion or termination of the trial.
The reason why TMF is so important is that it permits study to be independently recreated from these study records. TMF is a quality process, allowing to document all activity that has been performed during the study. This is critical in ensuring patient rights are respected & that regulators have access to robust, reliable clinical data at the time of marketing authorization application. It therefore helps to have well-structured procedures and processes in place that promote the collaborative exchange of study records between the CRO, the Investigational sites and sponsor study teams, to ensure that the TMF is complete and accurate.
Many CROs provide document management services to support trial master file management. In addition, there are a small number of companies that focus specifically on trial master file. Their services include process and quality consultancy, management and filing of trial master file content and provision of trial master file document management technology solutions (eTMFs).
