NEWS FROM THE ECF

Investigator’s signature on electronic Case Report Forms (eCRFs)

Best Practices

The intent of this document is to provide a framework for individuals’ risk‐based decisions and best practices for implementing solutions for investigators’ signature collection on data reported to sponsor.

Principal Investigators’ Signatures

Aligning the existing eCF best practices document with the most recent regulatory expectations

  • 4 March 2021
  • Author: Kenichi Nakano
  • Number of views: 8682
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Principal Investigators’ Signatures

Aligning the existing eCF best practices document with the most recent regulatory expectations

Audit Trail Review

  • 29 January 2019
  • Author: Webmaster1
  • Number of views: 8832
  • 0 Comments
Audit Trail Review

Best practices for meeting regulatory expectations for Audit Trail Review

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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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