NEWS FROM THE ECF

"When should audit trail begin?"

eCF published in Applied Clinical Trials 16-June-2021

"When should audit trail begin?"

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.

We welcome feedback! Please send to: REG@eclinicalforum.org 

Print
«October 2025»
MonTueWedThuFriSatSun
293012345
6789101112
13141516171819
20212223242526
272829303112
3456789

Upcoming events Events RSSiCalendar export