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Audit Trail Review (ATR) DMEG

In March 2023, the EMA released its final Guideline on Computerised Systems and Electronic Data in Clinical Trials, formalising regulatory expectations for the proactive review of audit trails for critical GxP data. Recognising that many Clinical Data Managers may find this new process complex, the Audit Trail Review (ATR) Expert Group aims to:

  1. Drive thought-leadership discussions around audit trail review.

  2. Gain and share operational knowledge and best practices within the group.

  3. Disseminate this knowledge to the wider Clinical Data Management community through presentations, white papers, and other resources.

By fostering collaboration and knowledge sharing, the ATR Expert Group seeks to support Clinical Data Managers in navigating and implementing effective audit trail review processes.

Audit Trail Review (ATR) DMEG

In March 2023, the EMA released its final Guideline on Computerised Systems and Electronic Data in Clinical Trials, formalising regulatory expectations for the proactive review of audit trails for critical GxP data. Recognising that many Clinical Data Managers may find this new process complex, the Audit Trail Review (ATR) Expert Group aims to:

  1. Drive thought-leadership discussions around audit trail review.

  2. Gain and share operational knowledge and best practices within the group.

  3. Disseminate this knowledge to the wider Clinical Data Management community through presentations, white papers, and other resources.

By fostering collaboration and knowledge sharing, the ATR Expert Group seeks to support Clinical Data Managers in navigating and implementing effective audit trail review processes.

Resources

The ATR DMEG has developed a range of resources to assist Clinical Data Managers in implementing effective audit trail review processes. These include comprehensive guides, such as “Getting Started with Audit Trail Review in Clinical Trial Data: An Essential Guide,” which offers practical advice and best practices. Additionally, the group has compiled documents addressing common questions and providing detailed answers to support the Clinical Data Management community.

ATR paper

Practical guide for Sponsors and CROs.

View Here 〉

ATR New

Sharing risk scenarios and use cases for Audit Trail Review.

View Here ⟩

atr2

An essential guide for data mangers.

View Here ⟩

atr resource 3

View the RBQM Symposium Slides.

View Here ⟩

atr 1

The ATR DMEG answers your Hot Topic questions.

View Here ⟩

Members

Jennifer Nielsen | DMEG Chair

Senior Specialist, Clinical Data Management | Lundbeck

Jennifer Logue Nielsen is an industry veteran who has been working within data management and clinical systems and technologies for many years, both in the United States and Denmark.  She joined Lundbeck in March 2021.
Jennifer Nielsen

Jennifer Nielsen | DMEG Chair

Senior Specialist, Clinical Data Management | Lundbeck

Jennifer Logue Nielsen is an industry veteran who has been working within data management and clinical systems and technologies for many years, both in the United States and Denmark.  She joined Lundbeck in March 2021.
Jennifer Nielsen

Interested in Joining?

The ATR DMEG 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.