"This is the best use of my time to remain current with what is going on in the industry."
の日本語版2025.2JP1が2025年6月30日にリリースされました。
The one file you will need to complete an assessment of your e-Source or e-File systems.
This guideline provides additional information to sponsors/CROs evaluating the use of eSRA forms for their organisation.
Comparison of V2025 to V2024 for both Form/S (eSource) and Form/F (eFile) and mapping to regulatory authority document statements
This is a categorised list of questions sent in from eSRA users (sites, sponsors, CROs) with the response from the eClinical Forum eSRA Team.
Version 2024JP1: Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳)
Version 2024JP1: Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
The 2025 version is now available in the eSRA Handbook and Assessment Forms V2025. This version will be removed on June 30, 2025.
Step-by-step with screen shots
Medical Informatics (Japan Society for Medical Informatics) article on use of eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical information systems."
Japanese Translation: eSRA Handbook and Assessment Forms V2025.2
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