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Securing the Integrity of Investigator-Owned Audit Trail Data
Courtesy of Endpoint Clinical
In light of increased scrutiny, focus and repeated guidance from clinical trial governing agencies regarding data integrity and computerized systems in clinical trials, in 2016 the International Council for Harmonisation (ICH) released E6(R2), their Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice, to help the industry implement “improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and reliability of trial results” (1). Surrounding this release and further to it, regulators have provided their insights through additional guidance, blogs, articles, and recorded workshop sessions to help further clarify one of the more prominent elements of the revision - data integrity requirements (2, 3, 4, 5, 6, 7, 8). There has been a particular focus on the validation of computer systems and the need for verification of data integrity, quality, and reliability through audit trail review.
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