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"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.
We welcome feedback! Please send to: REG@eclinicalforum.org
eCF Webinar November: FDA warning letters for audit trail analytics
FDA warning letters tell us what went wrong, but what could your audit trail analytics program have caught earlier? Join our upcoming webinar for a practical, in-depth look at an FDA warning letter and learn how to identify missed signals, uncover blind spots, and strengthen your audit trail review program.