"This is the best use of my time to remain current with what is going on in the industry."
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.
Version 2024JP1 (25-Nov-2024)
Japanese translation of ISF Assessment Handbook and Assessment Questionnaire (ISFA日本語訳)
Recording available from our public webinar which provided information on our 3 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials), eSRA (Site eSource-Readiness Assessment), and ISF (Investigator Site File System) Assessment. These tools are absolutely free to download as a service to the industry that we serve; we do not even collect email or other information.
Version 2024JP1 (20-May-2024)
Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
This is the ONE FILE that you need to perform an eSRA Assessment.
This is the ONE FILE that you need to perform an ISF Assessment.
How to assess site's systems for appropriateness of use for regulated clinical research. (Applies to both eSRA and ISF Assessment 2024.)
What has changed?
This is a categorised list of questions sent in from eSRA users (sites, sponsors, CROs) with the response from the eClinical Forum eSRA Team.
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."
Voluntary Investigator Site Survey survey concluded with 528 responses.
NOT A MEMBER?
Japanese translation of Inv Site File Assessment
eCF Birds-of-a-Feather Round-Table: “Navigating the Exciting and Confusing Landscape of AI Solutions for Document Automation”
This is an eCF Birds-of-a-Feather Round-table discussion on the new landscape of AI use in clinical research document automation. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis.
Webinar: eClinical Forum Membership Overview
The eClinical Forum is “For the members and by the members” and we want to be sure that we are providing our members with the best possible support for what they do. This webinar is targetted to our "primary representatives" from each eCF member organization, however anyone interested in understanding an overview of the eClinical Forum is welcome to attend. eClinical Forum membership is per company (not individual) and participation in eCF online events, project teams, and members-only publications are available to each person in a member organization without any additional cost.
eCF “Think GCP” Webinar: ICH E6(R3) for eCF Members
Presenter: Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)
About this topic: The final piece of the GCP renovation puzzle, revision 3 of ICH GCP. Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.