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NEWS FROM THE ECF

Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0

An Industry Position Paper

  • 20 April 2021
  • Author: Kenichi Nakano
  • Number of views: 6788
  • 0 Comments
Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0

The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based on Industry Feedback.  With various electronic data capture modalities becoming the norm and the growing regulatory focus on data collection traceability, audit trails which capture the who, what, when, and why of electronic data entry and amendments are a critical tool.  This paper outlines an industry perspective on maximizing the value of implementing the targeted, routine review of these extremely large datasets. It provides recommendations on risk-based use cases for audit trail review (ATR) and the corresponding desired reporting criteria, with suggestions on when to use visualizations and exception report listings to generate key, actionable insights.

Audit Trail Review

  • 29 January 2019
  • Author: Webmaster1
  • Number of views: 4750
  • 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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eCF “Birds of a Feather” Webinar:  Patient Voices: Transforming Healthcare Innovation

eCF “Birds of a Feather” Webinar:  Patient Voices: Transforming Healthcare Innovation

We will have a discussion with Savvy Cooperative on how engaging patient experiences can lead to better clinical, regulatory, and commercial outcomes.

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