ACDM News Item

Audit Trail Review DMEG Update – New Guide

Date: October 16, 2024

The Audit Trail Review (ATR) DMEG has been hard at work putting the finishing touches on a paper around ATR, titled Getting started with Audit Trail Review in Clinical Trial data: An Essential Guide.

This guide draws on our combined understanding and knowledge of this complex process. The goal of the paper is to demystify the implementation of an ATR process for clinical trial data, outlining the essential aspects, with suggestions and recommendations for how organisations can get started with this process. We share examples of findings and operational insights into the process, discuss CRO and Vendor perspectives, and conclude with thoughts on future directions in the ATR space.

We are pleased to share that the paper can now be read on our ATR DMEG page. Click here to find out more about our work and view the paper.

– Jennifer Nielsen, ATR DMEG Chair

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