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White Paper
eTMF and the eClinical Universe
How electronic trial master files work with other eClinical Systems to help you meet regulatory requirements
Jul 18, 2019
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  • eTMF and the eClinical Universe

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The completeness, timeliness and reliability of your eTMF system depends upon it receiving the correct documents as they become available, regardless of where they originate. This white paper provides multiple insights to help ensure that the eTMF will operate accurately and efficiently within the eTMF 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 authorities 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.


THE eCLINICAL UNIVERSE

The eTMF exists within a universe of eClinical systems that manage trial aspects such as logistics, safety, data collection and analysis, legal, and many others. Often, these systems are the sources of data or documents needed for the Trial Master File. An efficient and compliant eTMF must work in harmony with a variety of eClinical systems in order to contain the required information. Provides an overview of the eClinical systems that may provide data and documents to eTMF, or in a few cases, require access to documents stored in eTMF. Furthermore, these documents must be available in a timely manner. In recent guidance, the EMA has stated “The TMF should to be up to date, with documents placed in the TMF in a timely manner with the aim to maintain the TMF “inspection ready”. Furthermore, if documents required in the eTMF aren’t available in a timely manner, the system study and site milestones may be delayed. For example, site initiation and regulatory green light depend on receiving final clinical trial agreements. 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.


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