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"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 

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BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

BoF Round-Table Discussion: "eClinical Standards - Best practices for implementing"

This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing: “Can we develop best practices for implementing standards across sponsors and CROs of all sizes to drive efficiencies that result in medical advancements getting to patients faster?”

  • Can we facilitate a mechanism to share standards across organizations to avoid process changes from one trial to the next?
  • Can we track standard utilization across organizations to be data driven about when and how updates are needed?
  • With the increase in digital trials, what additional standards should we be considering?
  • What does an optimal standards committee look like? 
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