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.

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.

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.

The eSRA Questionnaire Version 2021 can be downloaded as part of the eSRA Handbook below.


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.

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

Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

Applied Clinical Trials (English, December 2018)

PHARMSTAGE (Japanese, October 2019)

1 October 2019 0
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eSRA Slides suitable to present to your organization

eSRA Slides suitable to present to your organization

15 July 2019 0
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Example of a completed eSRA V2019

Example of a completed eSRA V2019

1 April 2019 0
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eSRA Maintenance

eSRA Maintenance

1 March 2018 0
458
eSRA Use is Growing!

eSRA Use is Growing!

Feb 2018 Statistics on use of eSRA around the globe

19 February 2018 0
3062