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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.
Version 2023.2JP1 (18-Sep-2023)
Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
Version 2022.1JP1 (10-May-2022)
Version 2022.2 (25-May-2022; only the license agreement for those re-using in another form has been updated)
This is the ONE FILE that you need to perform an eSRA Assessment.
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."
This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021
Voluntary Investigator Site Survey survey concluded with 528 responses.
We are happy to announce an updated release of the eSRA (eSource Readiness Assessment) Handbook and Assessment Form. This 2019 version is an update, based on updates to FDA, EMA, PMDA and ICH regulatory documents. We encourage all Sponsors to use this assessment to assist in determining if data that originated in an investigator site system is suitable for inclusion in a clinical trial. We encourage all Investigator Sites to use this assessment tool and provide the resulting report to all Sponsors they are working with, thus avoiding the need to complete different assessments for each Sponsor. Full details of what this valuable tool provides can be found in the eSRA Handbook.
Click on the tab in the top-right of this website (www.eclinicalforum.org) "eSource Readiness Assessment (eSRA)".
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eCF Focus Session: EMA Guideline on Computerised Systems and Electronic Data in Clinical Research
A member from each eCF Project Team will present significant items in this guideline, from the perspective of their team topic.
Japanese translation of eSRA V2023
Birds-of-a-Feather Presentation and Discussion: Audit Trail Review Tools
The facilitators will share their experiences with the Boehringer-Ingelheim audit trail review tool … how it was developed, how it is being used, and what are the benefits. They welcome and encourage an open discussion on what tools and procedures other organizations are using for audit trail review.
eClinical Forum Hybrid Workshop, Barcelona, Spain
We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems
This hybrid workshop is available for face-to-face or remote participation. Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.
We encourage you and your colleagues to REGISTER NOW
Download Agenda HERE
Americas Autumn Workshop
eClinical Forum Autumn Workshop, Spring House, Pennsylvania
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Janssen in Spring House, Pennsylvania on October 24-26 2023.
This is an in-person workshop. There will be networking/social events on both evenings. Each eCF Member company in the Americas region will have 1 or 2 seats at this workshop. For those wishing to attend a remote eCF workshop, the eCF European workshop on Oct 4-6 will have similar topics and will be live-streamed and recorded. Information on the European workshop will be on our website soon.
eClinical Forum Autumn Workshop, Kobe, Japan
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Eli Lilly in Kobe, Japan on November 13-14 2023.
This is an in-person workshop. There will be networking/social events on the first evenings. Each eCF Member company in the APAC region will have 1 or 2 seats at this workshop. For those wishing to attend a remote eCF workshop, the eCF European workshop on Oct 4-6 will have similar topics and will be live-streamed and recorded.
eCF Technology Showcase: Viedoc Technologies AB – “The integrated eTMF/eISF to control study documentation management”
This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services. Viedoc Technologies, an eClinical Forum member company, will showcase their e-Trial Master File/e-Inestigator Site File solution. The eClinical Forum does not promote nor endorse any particular technology vendors.