"This is the best use of my time to remain current with what is going on in the industry."
With the increased focus on data integrity from regulators, the routine use of audit trail review as a tool is required. This team will explore and provide guidance on what is the recommended scope for review, provide definitions, determine ‘what’ data (and in what part of the data lifecycle) should be reviewed with an audit trail vs other data integrity controls and finally recommend ‘how’ an audit trail review should be conducted (frequency, visualizations, exception reports etc). A white paper will be released to eCF members in 1Q 2020 with the anticipation of releasing it to the public by 1Q 2021.
eCF Views & News
We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.
Public release of the Computerised Systems Essential Records (CSER) List
The Clinical Forum’s Essential Records Team is pleased to announce the public release of the rComputerised Systems Essential Records (CSER) List.
This CSER List is designed to support sponsors in identifying, selecting, and documenting the essential data and metadata that must be retained to accurately reconstruct the conduct of a clinical trial after decommissioning from the computerised system.
eCF Webinar September "ICH E6 (R3) Annex 2"
Join us for a discussion on CH E6 (R3) Annex 2 and its role in modernizing GCP to better reflect the evolving landscape of clinical research on Wednesday, September 9, 2026.
Americas Autumn Workshop, October 13-15, 2026, Bloomington IL, USA, hosted by GenInvo
APAC/Hybrid Autumn Workshop, October 21-22, 2026, Shanghai, China, hosted by Clario
Europe/Hybrid Autumn Workshop, October 27-29, 2026, Zurich, Switzerland, hosted by BSI Software