The eSOURCE-READINESS ASSESSMENT TOOL (eSRA)

The tool contains questions based on regulations and regulatory agency guidelines for clinical research data sources and should be used to evaluate the suitability of an Investigator Site computerized system to provide data for clinical trials. An eClinical Forum team, comprised of CRAs and Data Managers from different clinical research sponsor organizations and CROs and representatives from sites, has produced the "eSource-Readiness Assessment", otherwise known as "eSRA" for sites to perform a self-assessment of their computerized system's ability to be compliant with clinical research regulations.

Clinical research draws on a combination of data collected during a clinical trial and historical medical information relating to the research subject(s). Many of the data points needed for clinical research are originating in Electronic Health Record Systems, making them "eSource" for clinical research. Even if these data points are not used directly from the site's healthcare system, but are re-entered into a Sponsor's system for a clinical trial, the source of the information (the healthcare system) must still be confirmed as compliant with standards set forth in clinical research regulations and applicable guidance documents.

The eSRA Questionnaire Version 2024 can be downloaded as part of the eSRA Handbook below.  (This version incorporates changes based on the EMA Guideline on computerised systems and electronic data in clinical trials.)

Notice to those intending to include eSRA in their own materials: Copyrighted by the eClinical Forum 2024. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the eSRA Handbook and “Implementing eSRA” Guide. We welcome eSRA to be used in other formats, however, it is required that eSRA text be used exactly, that all eSRA questions are included, that your use of eSRA is updated when eCF eSRA is updated, and that eClinical Forum is notified in writing and credited. By using these materials, you acknowledge the terms and conditions for use.  The eClinical Forum is only responsible for the eSRA materials as distributed via the eClinical Forum website. If using the eCF form, downloaded from this website, in it's original format, there is no need to notify eCF.

Stay Current!!

As new regulations are released or updated, the eClinical Forum will evaluate if the eSRA questions should be updated. To be notified of future releases of the eSRA Questionnaire, 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 eSRA.

Sponsors & CROS -- Please take our very brief survey regarding how you are using eSRA.  This will help us improve eSRA. Survey link: eCF eSRA Survey (eclinicalforum.org) THANK YOU!!!

Do we keep a list of sites that have completed eSRAs?

We have frequently been asked if we can provide a list of which sites have already completed an eSRA. Due to privacy laws in different countries, eClinical Forum does not keep such a list. We supply the eSRA questionnaire, free of charge, to anyone who wants to use it. We encourage sponsors to keep a list for themselves of which sites they have received a completed eSRA from. We encourage sites to store their completed eSRA in a central location (such as their IT department) so that other groups within the same organization / using the same electronic healthcare system, can use the completed eSRA as a basis to complete their own eSRA.

eSRA RESOURCES – Scroll to see all resources

eCF Technology Showcase: AiCure: Using AI to improve patient adherence, compliance, and retention

Published on 01 February 2025

eCF Technology Showcase: AiCure: Using AI to improve patient adherence, compliance, and retention

March 12, 2025

Event date: 12/03/2025 Export event

eCF Technology Showcase: AiCure: Using AI to improve patient adherence, compliance, and retention

H.Code by AiCure is the world’s first patient engagement AI, a comprehensive platform that extends the reach of your care team into the patient’s home and life—more seamlessly, frequently, and effectively. 

We will discuss the importance of engagement with clinical trial participants and share innovative strategies to improve it. Specifically, we will discuss:

  • Simplifying clinical studies by reducing the number of technologies used
  • Importance of active engagement between clinical sites and trial participants
  • Utilizing predictive analytics to inform patient interventions for improved adherence, compliance, and retention

Presenter: Megan Gross, MS, PGC, Associate Director of Clinical Site Services at AiCure

Date: Wed, 12-March-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 receiving a link to the recording.

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

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

Registration: Anyone from an eCF member organisation may register using this link: eCF Tech Showcase: AiCure: Using AI to improve patient adherence, compliance, and retention

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.

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