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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.
Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?" It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.
Authors: Jules Mitchel, PhD, is the Co-Founder of Target Health, US. Yumi Sugiura is the Associate Director of Global Data Management & Centralized Monitoring for Bristol Myers Squibb, Japan. Valdo Arnera, MD, is a Scientific Advisor for ERT, Switzerland. Greg Gogates is the Vice President of Quality/Regulatory for Fasor, US. Alan Yeomans is a Quality Manager for Viedoc Technologies, Sweden. Devry Spreitzer is a Senior Director, Data Integrity Quality Assurance for Astellas Pharma Global Development, US. Suzanne Bishop is the Americas Administrator for eClinical Forum.
Link to article: When Should the Audit Trail Begin? (appliedclinicaltrialsonline.com)
We welcome feedback! Please send to: REG@eclinicalforum.org
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eCF Focus Session: Audit Trail Review in Practice
The eClinical Forum published a joint paper with SCDM in April 2021, titled “Audit Trail Review: Key Tool to Ensure Data Integrity”. (If you missed it, you can download it here: Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 (eclinicalforum.org) ) Now that members have had time to review the paper and perhaps discuss with colleagues, we thought it is a good time to hear what different members are doing, or are planning to do, regarding audit trail review. This focus session will not be discussing the paper, but rather will be discussing what practices around audit trail review our members are taking.
This is a two-hour focus session. The first hour will be presentations of case-studies from eClinical Forum members. The second hour will be a round-table discussion.