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

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
15645
Free Public Webinar: Assessment of Investigator Site Systems that may originate source for clinical trials & the free eSRA tool (Japanese)

Free Public Webinar: Assessment of Investigator Site Systems that may originate source for clinical trials & the free eSRA tool (Japanese)

eSRA (eSource Readiness Assessment) is a tool to assess the data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities. eClinical Forum issued a Japanese translation of eSRA Handbook in July.  This seminar is targeted for Japanese audiences, and eSRA will be explained in Japanese.
eSRA (eSource Readiness Assessment)はEHR/EMRなどの医療機関のシステムのデータを治験に利用できるかどうか評価するためのツールであり、7月にeSRA Handbookの日本語版がリリースされました。本Webinarは日本の方を対象にeSRAをご紹介するものです。ぜひご参加をお待ちしています。

9/9/2020 - 9/10/2020 0
800
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
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
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
4869
eSRA Slides suitable to present to your organization

eSRA Slides suitable to present to your organization

15 July 2019 0
2879
eSRA Maintenance

eSRA Maintenance

1 March 2018 0
459