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Audit Trail Review DMEG

Audit Trail Review Group

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.

Audit Trail Review Group members

Alan Yeomans
Quality Manager | Viedoc

Vishal Kapoor
Group Manager, Clinical Data Sciences & Systems | Terumo

Hannah Bausch
Senior Clinical Research Professional | Esculape

Tracey Lavery
Manager, Clinical Data Management | ONO Pharma UK ltd

Nadia Petiot
QA Auditor & Data Management Expert | Focus Data Science

Oyiza Momoh
Manager, Clinical Data Manager | GSK

Marcus Schwabedissen
Chief Operating Officer, Senior Executive Consultant | QFINITY

Jennifer Bradford
Director of Data Science | Phastar

Sverre Bengtsson
Co-founder | Viedoc

Richard Moore
Senior Lead Data Manager | PRA Health Sciences

Nina Reyes
Manager Clinical Data Management | IQVIA

Andy Richardson
Director | Zenetar Ltd

Tim Armitage
Manager, EMEAR Enterprise Solution Consulting | Medidata, a Dassault Systèmes company

Santosh Karthikeyan Viswanathan
Technical Director, Clinical Programming | AstraZeneca

Natalia Sofia
Senior Clinical Data Manager | MSD Merck Sharp & Dohme AG

Peter Sec
Associate Manager, Clinical Data Sciences | Premier Research

Emma Wrixon
Senior Clinical Data Manager | Labcorp

Doug Bain
Chief Technology Officer | KCR

Alberto Clemente
Data Scientist, Clinical Data Sciences | Premier Research

Shuchi Thakur
Associate Director, Project Data Manager | AstraZeneca

Jennifer Nielsen (Chair)
Senior Specialist, Clinical Data Management | Lundbeck

Sverre Bengtsson
Co-founder | Viedoc

Rich Davies
VP, Solution Expert | CluePoints

Tanya du Plessis
Chief Data Strategist and Solutions officer | Bioforum

Alex Franklin
Project DM Director – Immuno-Oncology | GSK

Amy Neubauer
Director, Global Clinical Data Management Operational Excellence | Alexion