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 2023 can be downloaded as part of the eSRA Handbook below.  

Notice to those intending to include eSRA in their own materials: Copyrighted by the eClinical Forum 2023. 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

White Paper Released by the Artificial Intelligence and Machine Learning Working Group

White Paper Released by the Artificial Intelligence and Machine Learning Working Group

The Artificial Intelligence and Machine Learning Team is pleased to announce the public release of theirwhite paper titled "AI state-of-play around clinical research"

The white paper were written by a joint task force from the eClinical Forum and Eucrof.

2 October 2023 0
70
Japanese translation of eSRA V2023

Japanese translation of eSRA V2023

Version 2023.2JP1 (18-Sep-2023)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

17 September 2023 0
247
Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team

Three white papers released by the eCF/EUCROF Archiving and the Decommissioning Team

The Archiving and Decommission Team is pleased to announce the public release of three white papers:

  • "The Decommissioning of Computerised Systems Used in Clinical Trials" 
  • "Nature of a Distributed Trial Master File ‐ Practical Aspects"
  • "Data Formats Used in Clinical Trials"

These white papers were 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.

12 April 2023 0
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eSRA V2023 (eSource-Readiness Assessment) Handbook and Questionnaire

eSRA V2023 (eSource-Readiness Assessment) Handbook and Questionnaire

This is the ONE FILE that you need to perform an eSRA Assessment. This 2023.2 version has a correction as the previous version incorrectly had two question 26. (July 1, 2023)

24 March 2023 0
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Implementing eSRA - Sponsor Perspective

Implementing eSRA - Sponsor Perspective

How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2023)

24 March 2023 0
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Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

24 March 2023 0
591

Differences between eSRA V2023 to eSRA V2022

What has changed?

24 March 2023 0
371
eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2022"

ABOUT THE ECF REQUIREMENTS:  The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial.  We have reviewed regulatory documents from the FDA, EMA, PMDA, NMPA, MHRA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems, that source or manage data which will become part of a regulated clinical trial, are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

23 March 2023 0
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