Version 2025 has been released!!! This version includes updates based on ICH E6(R3) Good Clinical Practice. eSRA has been used globally since 2016!!

The eClinical Forum offers 2 absolutely free system assessment forms that consist of regulatory-based questions for evaluating the suitability of an investigator site system to provide data/records for clinical trials.Both forms are part of the eSRA Handbook which provides guidance to sites on how to complete the forms. We request that Sponsors and CROs do not separate the forms from the handbook. Sites may separate the forms from the handbook after completion such that they are only sharing and storing the completed forms.

Form/S for e-Source Systems (e.g. Electronic Health Record Systems (EHRs))
Form/F for e-Investigator Site File Systems
A Japanese translation of eSRA V2025 is anticipated to be released by the end of June.

Notice to those intending to include eCF Site System Assessment Forms in their own materials/applications: the forms are copyrighted by the eClinical Forum. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the eSRA Handbook and “Implementing eSRA” Guide. By using these materials, you acknowledge the terms and conditions for use as described in the eSRA documents. The eClinical Forum is only responsible for materials as distributed via the eClinical Forum website. If using the eCF forms downloaded from this website in original formats, there is no need to notify eCF.

Stay Current!!

eSRA materials are updated annually and released at the end of Q1. To be notified of future releases and/or to provide feedback to the team, please send an email to eSRA@eClinicalForum.org. Your email address will not be used for purposes other than to inform you of updates to eCF Site System Assessments.

Do we keep a list of sites that have completed eCF Site Assessments?

Due to privacy laws in different countries, eClinical Forum does not keep such a list. We encourage sponsors to keep a list for themselves of which sites they have received a completed assessment from. We encourage sites to store their completed assessments in a central location (such as their IT department) so that other groups within the same organization / using the same computerised system, can use the previously completed assessment as a starting point.

eCF Site System Assessment Resources – Scroll to see all resources

Published on 18 December 2024

eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping

5-February-2025

Event date: 05/02/2025 Export event

Technology Showcase: eClinical Solutions: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping

The hype and promise of fully automated mapping have run counter to the reality of complex, messy source data. In this session, we’ll present an approach that aims to bridge that gap – a guided user experience for automated mapping. Rather than being a black box turnkey solution, here the focus is on having a human in the loop, an expert involved in the most complex aspects, while easing the process for the user with an AI-guided experience. Most attempts at automated SDTM solutions have met the 80/20 rule, capable of automating 80% of mappings. This session will address and consider the challenges and limitations faced by these solutions and present an approach that closes in on the 20% so that we can arrive at a fully automated system that keeps the human in the loop.

Presenter: Achilleas Zaras, eClinical Solutions

Date: Wed, 5-Feb-2025 Duration: One hour

Time: We apologize for the inconvenient time in some time zones. In addition, we will record the session. Please also register if you are interested in the recording.

Webinar A (Europe/Asia facing):

Webinar B (Americas/Europe facing):

Recording: A link to the recording will be provided the next day, to those who have registered for this.

Open To: Staff from eClinical Forum member companies (gratis). For information on eCF membership, please see www.eclinicalforum.org/membership or send an inquiry to info@eclinicalforum.org.

Background: 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, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors. Any member can participate that has an interest in the topic area. Any eClinical Forum Member may suggest or present a Technology Showcase. For more information, please reply to webinars@eclinicalforum.org.

What You Need to Do: Register using the link: eCF Tech Showcase: eClinical Solutions: Impact of AI Driven Automation and Data Transformation

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Author: Suzanne Bishop (Americas Administrator)

Categories: EVENTS, Webinar/Telecon, PRIVACY, Visible by Public

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