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eTMF

What is eTMF? eTMF is a type of software that provides a digital space for creating, tracking, and storing the Trial Master File (TMF). Historically, the TMF refers to the documents involved in a clinical trial from initiation to close out. These documents are not only used to track the progress of the trial, but also form the basis of regulatory reviews and future approvals.

What is the need for eTMFs? 

Implementation of eTMFs has helped overcome the obstacles commonly faced by traditional TMFs By providing a centralized, electronic record system, eTMFs have improved the clinical trial and regulatory process by:

  • Decreasing space and cost of keeping physical documents.
  • Allowing real-time and efficient retrieval of data.
  • Making timely updates to trial information.
  • Improving compliance with regulatory requirements.
  • Improving efficiency and streamlining SOPs.
  • Including quality control measures to prevent errors.
  • Integrating additional functions to visualize data for analysis.

Source: Rupani, Z. (2020). Clinical trial master file migration: A preordained step for a centralized electronic trial master file. Perspectives in Clinical Research, 11(4), 139. https://doi.org/10.4103/picr.picr_106_19