Tejas Venkatesh
Independent Researcher
Karnataka, India
Abstract
The increasing complexity of clinical trials has driven the need for robust, centralized documentation systems to ensure regulatory compliance, operational efficiency, and audit readiness. The Electronic Trial Master File (eTMF) system has emerged as a transformative solution in this context, offering standardized digital processes for organizing, storing, and managing essential trial documentation. This manuscript explores the impact of eTMF systems on clinical documentation efficiency and audit preparedness, particularly focusing on their ability to streamline workflows, reduce errors, enhance accessibility, and improve regulatory inspection outcomes. A systematic review of literature reveals a growing adoption of eTMF platforms, with early data supporting their utility in improving documentation timelines and oversight. The paper analyzes how the digital transition from paper-based to electronic TMFs has influenced stakeholder collaboration and operational excellence. By integrating qualitative insights and comparative assessments of paper-based and electronic systems, this study outlines both the benefits and limitations of eTMF adoption, contributing to the broader understanding of digital transformation in clinical trial management.
Keywords
electronic trial master file, clinical documentation, audit readiness, regulatory compliance, digital transformation
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