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

eCF Free Public Webinar: Requirements for Electronic Data for Regulated Clinical Trials, and associated Investigator Site eSource-Readiness Assessment

eCF Free Public Webinar: Requirements for Electronic Data for Regulated Clinical Trials, and associated Investigator Site eSource-Readiness Assessment

The eClinical Forum is pleased to offer a free public webinar – the same as was presented to the FDA CDER Health IT Board on 6-April-2021 – to provide information on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA (Site eSource-Readiness Assessment).

4/28/2021 0
298
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
15640
Implementing eSRA: Sponsor Perspective

Implementing eSRA: Sponsor Perspective

How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2021)

15 March 2021 0
525
What is the difference between the eSRA 2020 and eSRA 2021?

What is the difference between the eSRA 2020 and eSRA 2021?

15 March 2021 0
1620
JAPANESE TRANSLATION of eSRA Handbook and Webinar

JAPANESE TRANSLATION of eSRA Handbook and Webinar

This is the 2021JP1 version.

14 March 2021 0
2634
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)

1 March 2020 0
5234
Webinar on “Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool”

Webinar on “Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool”

Recording and slides available

25 February 2020 0
1700
RESULTS: Investigator Site Survey

RESULTS: Investigator Site Survey

544 responses were received to the Site Survey between 26 April 2016 and 5 August 2019. After removing 16 responses with no clinical trial experience, 528 responses were retained for analysis, Results of the survey are presented in the attached download together with comparison with 2009 results where appropriate. The intention is to post further analyses by time period and region.

31 October 2019 0
21474