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 Views & News

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.

1 October 2024 0
843
Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1

Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1

The eClinical Forum is happy to announce the public release of a position paper titled “Decentralized TMF Archives and The Decommissioning Of Computerised Systems Used In Clinical Trials”.  This position paper was written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.

ABOUT THE POSITION PAPER: Following the completion of a clinical trial, the essential documents that make up the TMF (Trial Master File) are retained and archived by the sponsor, the investigator and, in some cases, sub-contractors to the sponsor and/or investigator. The position paper highlights 11 key positions: seven positions concerning the archiving of the TMF and four positions concerning the archiving of the electronic data. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices.

26 February 2021 0
4101
Webinar: eClinical Forum Membership Overview

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.

09/01/2025 0
1
eCF Birds-of-a-Feather Round-Table: “Navigating the Exciting and Confusing Landscape of AI Solutions for Document Automation”

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.

09/12/2024 0
4

Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023

The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to easily check the requirements that were in place in a particular year.

8 November 2024 0
59

Recording of eCF Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments

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.

18 September 2024 0
489
Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

The eClinical Forum is releasing its 7th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA, EMA, PMDA, MNPA, MHRA and ICH , and boils them down into 37 unique statements or "eCF Requirements".

15 July 2024 0
1161
2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

The "eCF Requirements" Members Release V2024 has been released.  This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to be able to produce such a comprehensive list of compliance requirements for  electronic systems that will manage data used in regulated clinical research, against regulations and guidances from 40 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH and ISO.

5 July 2024 0
249