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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

 

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Audit Trail Review

  • 29 January 2019
  • Author: Webmaster1
  • Number of views: 4065
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Audit Trail Review

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.

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