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The eClinical Forum is happy to announce the public release of a position paper titled “Decentralized TMF Archives and The Decommissioning Of Computerised Systems Used In Clinical Trials”. This position paper was written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.
ABOUT THE POSITION PAPER: Following the completion of a clinical trial, the essential documents that make up the TMF (Trial Master File) are retained and archived by the sponsor, the investigator and, in some cases, sub-contractors to the sponsor and/or investigator. Many of the computerised systems used during a trial are only used during the active data collection stage of the trial, which is often a shorter period of time than the retention period required for the archiving of the essential documents of the trial.
The position paper discusses the needs and proposed practical directions for archiving of clinical research. The task force has included representatives the pharmaceutical industry, investigator and institution sites, contract research organisations and vendors of computerised systems to the clinical trial industry. The paper highlights 11 key positions: seven positions concerning the archiving of the TMF and four positions concerning the archiving of the electronic data. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices.
The position paper is the product of unparalleled knowledge and experience, and nearly three years of continuous efforts by the EUCROF and eClinical Forum Joint Task Force on Archiving and Decommissioning.
eCF Spring 2026 Workshops Announced!
We are happy to announce our Spring workshops!
Europe/Hybrid: Hosted by Servier outside of Paris on April 14-16 (this will be livestreamed as well)
Americas: Hosted by YPrime outside of Philadelphia, PA on April 28-30
Asia: Hosted by Novartis in Tokyo, Japan on April 2-3
Release of the 2026 electronic Site Readiness Assessment (eSRA)
The latest version of eClinical Forum’s eSRA is now available for download, free and open to the industry. If you work at a clinical research site, eSRA is designed to help you. It's a standardized checklist that lets you evaluate your readiness to support electronic clinical trial processes before a study starts, so you can identify gaps early, not mid-trial.
Conclusion of the eCF Spring Workshops 2026
With the conclusion of the eClinical Forum Americas Workshop last week, the Spring 2026 workshop season has officially come to a close. This year’s workshops focused strongly on the current and future use of Artificial intelligence in clinical research. Planning for the Autumn 2026 Workshops will begin soon.