Audit Trail Review Data Management Expert Group (DMEG)
What is a DMEG?
A Data Management Expert Group (DMEG) is a specialised forum established by the Association for Clinical Data Management (ACDM) to bring together professionals with deep expertise in specific areas of clinical data management. These groups aim to foster collaboration, share best practices, and drive forward the industry’s standards and innovations. Each DMEG focuses on a unique aspect of data management, supporting the ACDM community by providing insights, organising events, and producing thought leadership content.
ATR DMEG
With the release of the final EMA Guideline on computerized systems and electronic data in clinical trials in March 2023, regulatory expectations around proactive review of audit trails for critical GxP data were formalized—but many CDMs may not know where to start with this new, complex process.
The aim of the ATR (audit trail review) Expert Group is therefore two-fold: to drive thought-leadership discussions around this new process, gain and share operational knowledge and best practice amongst the group, and then to share that knowledge with the wider CDM community through presentations, white papers, etc.
We welcome new members and input to this group, which formed in 2023. If you would like to be a part of the discussions and shape the future of this new process, please click here.
Resources developed by the ATR DMEG
Getting started with Audit Trail Review in Clinical Trial data: An Essential Guide: Symposium Slides
Date: November 7, 2024
Getting started with Audit Trail Review in Clinical Trial data- An Essential Guide
Date: September 23, 2024
Audit Trail Review DMEG Chair
Jennifer Nielsen (Chair)
Senior Specialist, Clinical Data Management | Lundbeck
She has been working with the topic of audit trial review since 2019 and had key roles in implementing audit trail review in her current and previous role.
She has a special interest in external collaborations and has been active in other cross-industry collaborations such as Transcelerate as well as local groups like the Danish Association of Data Management. She looks forward to chairing this new expert group and the work ahead.
In her free time, when not pondering the complexities of audit trail review, she burns off extra energy by swimming, both in the pool and open water. And in true Copenhagen-er style, she enjoys riding her bike to work as much possible during the spring and summer months.