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The current regulatory expectation is the investigators review and sign-off the data entered into eCRFs and other data collection tools at critical timings (including prior to interim analysis and the final analysis) in a timely manner. eClinical Forum issued a best practices document titled “Investigator’s signature on electronic Case Report Forms (eCRFs) in 2017. This team will review and align this existing document with most recent regulatory expectations on signatures collection on eCRF and eCOA data. A draft is anticipated in October 2021 and the release to the members by end of December 2021.
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 Views & News
We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.
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.
Birds-of-a-Feather Round-table on eCOA Topics
Open To: Staff from eClinical Forum member companies gratis (If you are not an eCF member, please review our website Membership for membership information or contact info@eclinicalforum.org )
eCF Webinar: "Strategies for Implementing Audit Trail Review"
The eCF Audit Trail Review Analytics (ATRA) team anticipates releasing their white paper "Strategies for Implementing Audit Trail Review" to eCF members in early September. This webinar will provide an overview of the paper as well as delve into some specific areas.
eCF Autumn Workshops Announced!
We are happy to announce our 3 Autumn workshops!
Americas: Hosted by Eli Lilly in Indianapolis on October 21-23
Europe/Hybrid: Hosted by Medidata in London on Nov 4-6 (this will be livestreamed as well)
Asia: Hosted by Kyowa Kyrin in Tokyo on Nov 13-14