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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
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
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eCF BoF Round-table: Utilization of Scribes for eCOA
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 “The utilization of scribes is needed for the conduct of clinical assessments within eCOA. Therefore, eCOA needs to be built in a manner that meets the regulatory requirements for scribing, to ensure all individuals participating in the assessment are audit trailed.”
"When should audit trail begin?"
eCF Spring Workshops Announced
Europe/Global hybrid workshop -- April 16-18
Americas in-person workshop -- April 30 - May 2
eCF Spring Workshop in Zurich, Switzerland
This workshop is hosted by BSI Life Sciences at their office in Zurich, Switzerland on April 16-18. It will also be live-streamed and recorded for access by all eCF members.
eCF Spring Workshop in Ridgefield, Connecticut USA
Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.