eTMF And The eClinical Universe

The electronic Trial Master File (eTMF) is an increasingly important eClinical technology used to manage the set of essential documents required for every clinical trial.  The eTMF is a specialized form of an Electronic Document Management System (EDMS) optimized to manage the processes around creating or uploading clinical trial documents and completing the workflow processes needed to finalize, secure and archive them.  While small Phase 1 trials may only have a few documents, large Phase 3 or Phase 4 trials require tens of thousands of documents.  As a result, better systems and increased automation offer the opportunity for meaningful cost and time savings.

The eTMF contains a wide variety of documents that the regulatory authorizes have determined are necessary to allow the conduct of the clinical trial, the integrity of the trial data and the compliance of the trial with GCP to be evaluated  – often augmented by additional documents required by the sponsor.  Each trial has its own specific set of required documents based on the trial details such as the nature of the investigational product, the countries in which the trial is being conducted, or the phase of the study.  Completeness and accuracy of the TMF is a significant regulatory requirement, and regulatory agencies conduct audits of TMFs by direct examination of sponsors’ eTMF systems.