Electronic Trial Master File (eTMF)
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An Electronic Trial Master File (eTMF) is a trial master file that is an electronic archive.
References
2022
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/electronic_trial_master_file Retrieved:2022-1-3.
- An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format. It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies. The term eTMF encompasses strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. An eTMF system consists of software and hardware that facilitates the management of regulated clinical trial content. Regulatory agencies have outlined the required components of eTMF systems that use electronic means to store the content of a clinical trial, requiring that they include: Digital content archiving, security and access control, change controls, audit trails, and system validation.
2020
- (Rupani, 2020) ⇒ Zainab Mehboob Rupani. (2020). “Clinical Trial Master File Migration: A Preordained Step for a Centralized Electronic Trial Master File.” Perspectives in Clinical Research 11, no. 4
- ABSTRACT: The need to speed up clinical trial processes in a cost-effective manner, increased importance of data integrity, and ensuring timely compliance to regulatory requirement updates regarding the Trial Master File (TMF), has made the pharmaceutical industry delineate the requirement to maintain a centralized TMF with quality control. With the exponential increase in the number of sponsors using centralized electronic TMF (eTMF), the shift of trend positively impacts the need for data migration requirements in the TMF space. With an objective to serve the readers handling migration projects, this review article discusses the data migration requirements in clinical operations and eTMF in clinical trials, possible techniques to consider avoiding anticipated roadblocks, and a few other key points. The article also focuses on steps to be taken post migration to ensure meeting the quality of the migrated data in terms of regulatory compliance.
- KEYWORDS: Data Migration, Drug Information Association Reference Model, International Conference on Harmonization Good Clinical Practices, Medicines and Healthcare Products Regulatory Agency, Quality, risk-based approach, Trial Master File.