NEWS FROM THE ECF

Essential Metadata

Essential Metadata

The goal is to produce a list and description of the essential metadata required to be able to reenact the events of the trial. This list will be used for industry-wide consensus building. This team began in Dec 2023 and phas had discussions with the EMA IWG eSource team in June 2024 and will meet with the IWG again in Nov 2025. The team has presented at the eCF Autumn 2024  and Autumn 2025 workshops and will continue working on deliverables.

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eCF Views & News

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.

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Public release of the Computerised Systems Essential Records (CSER) List

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.

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