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.

Sponsors -- We would like to know which sponsors are using eSRA, either a) as a direct download from our site, or b) as a basis for their own site-system assessment questionnaire. Please contact us at eSRA@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

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021 – on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA (Site eSource-Readiness Assessment).

5 May 2021 0
1947
eCF Webinar: Connecting Clinical Research and Healthcare: The Vulcan HL7 Accelerator Opportunity

eCF Webinar: Connecting Clinical Research and Healthcare: The Vulcan HL7 Accelerator Opportunity

HL7 FHIR (Fast Healthcare Interoperability Resources) is a standard describing data formats and elements and an application programming interface for exchanging electronic health records. The standard was created by the Health Level Seven International health-care standards organization.  Vulcan is an HL7 FHIR Accelerator that brings together stakeholders from across the translational and clinical research communities in order to bridge existing gaps between clinical care and clinical research, strategically connect industry collaboratives, maximize collective resources, and deliver integrated tools and resources.  HL7 FHIR is the path forward to bridge clinical care and clinical research. A global collaboration between all translational and clinical research stakeholders to co-develop out the standard, it will allow for a reproducible, scalable process for data exchange. The presenters will share not only the conclusions drawn from use cases developed up to this point, but will also provide insight into the future direction and priorities of Vulcan.  

17/11/2021 0
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eSRA was used in a Japanese research paper on data quality of medical information systems

eSRA was used in a Japanese research paper on data quality of medical information systems

Medical Informatics, a publication of the Japan Society for Medical Informatics, published an article which used eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical information systems."

26 August 2021 0
383
eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

Version 2021

This is the ONE FILE that you need to perform an eSRA Assessment.

15 March 2021 0
22313
Recording: Use of eSRA to fulfill Sponsor responsiblity for assessing site systems

Recording: Use of eSRA to fulfill Sponsor responsiblity for assessing site systems

25 February 2020 0
3047
RESULTS: Investigator Site Survey

RESULTS: Investigator Site Survey

Voluntary Investigator Site Survey survey concluded with 528 responses.

31 October 2019 0
23534
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

1 October 2019 0
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eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019

eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019

We are happy to announce an updated release of the eSRA (eSource Readiness Assessment) Handbook and Assessment Form. This 2019 version is an update, based on updates to FDA, EMA, PMDA and ICH regulatory documents. We encourage all Sponsors to use this assessment to assist in determining if data that originated in an investigator site system is suitable for inclusion in a clinical trial. We encourage all Investigator Sites to use this assessment tool and provide the resulting report to all Sponsors they are working with, thus avoiding the need to complete different assessments for each Sponsor. Full details of what this valuable tool provides can be found in the eSRA Handbook.

Click on the tab in the top-right of this website (www.eclinicalforum.org) "eSource Readiness Assessment (eSRA)".

25 March 2019 0
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