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WHO WE ARE
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
The REG team reviews, evaluates and interprets documents from regulatory authorities. The team is comprised of regulatory professionals from all aspects of eClinical Forum (pharma, technology vendors, support vendors, sites).
Maintaining the free eSRA (eSource-Readiness Assessment) questionnaire used by sites to self-evaluate electronic systems originating or managing data for clinical research.
The eClinical Forum held an open discussion with members from pharma, CROs, and associated software vendors, to talk about this draft FDA guidance on Jan 8, 2013. The resulting comments are a consensus of member opinion. They have been submitted to the FDA on March 12, 2013.
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Japanese Translation: eSRA Handbook and Assessment Forms V2025.2
の日本語版2025.2JP1が2025年6月30日にリリースされました。
eCF "BoF" Round table: "A Chat about eCOA"
eClinical Forum Birds-of-a-Feather round-table webinars focus on the details of a specific topic. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.