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The eClinical Forum Archiving and Decommission Team is pleased to announce the public release of three white papers:
These white papers were 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 PAPERS: These white papers provide details of the positions described in a position paper titled “Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials” released on 26/Feb/2021.
Nature of a Distributed Trial Master File ‐ Practical Aspects: The Essential records consist of trial-specific, non‐trial-specific documentation, and data. The non‐trial specific essential records may be retained separately and signposted in the sponsor (e)TMF. The location of these records will vary depending on the type and source of the records in question. Consequently, the whole (e)TMF will span across multiple locations and be distributed among multiple parties. The aggregation of trial and non‐trial specific essential records must allow for the seamless reconstruction of clinical development activities, must be open to audits and inspections, and must fulfill all regulatory and legal purposes for the applicable full retention periods. This white paper is intended to provide hands‐on practical guidance on (e)TMF implementation by describing examples of risks in practice with proposed recommendation(s).
The Decommissioning of Computerised Systems Used in Clinical Trials: Clinical trials typically involve the use of multiple computerised systems and many of these systems are rarely developed for use in one trial alone. Instead, specific trial configurations are built on common platforms across multiple sponsors and contract research organisations (CROs). This white paper addresses the decommissioning of computerised systems such as EDC/eCOA systems used in clinical trials
Data Formats Used in Clinical Trials: There are disparate views in our current climate on how data should be archived and handled. This follows regulatory guidance that expects information to be available in a way that allows queries whilst understanding that such formats are not necessarily practical over the full retention lifetime. This white paper explains the options, risks, and benefits of using a flexible multiformat approach to ensure recall can be conducted in the future.
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.