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eSource Readiness Assessment (eSRA)

The eSource Readiness Assessment Tool (eSRA) 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 research.

 

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 in their electronic state for clinical research, but are printed from the electronic health records and then 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, has produced the "eSource-Readiness Assessment", otherwise known as "eSRA" for sites to perform a self-assessment of their computerized systems ability to be compliant with clinical research regulations. 

                      The eSRA Template Version 2018.1 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 Template, 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. 

Please Help! Be a part of the solution -- An easy way for you to participate in the improvement of our e-clinical environment!  We welcome your feedback on the assessment tool. We would also like to use your completed assessment, in an anonymized way, as part of a summary of the ability and needs of site's computerized systems. We are compiling statistics regarding site abilities, to provide information to software vendors and others, regarding areas for improvement.  It is our goal that all healthcare systems become compliant with clinical research regulations and guidance. Please help us -- send your completed assessment to eSRA@eClinicalForum.org You are welcome to strip off your organization identifying information before sending, however, this is not necessary as we promise to not use this portion of the assessment for our summary purposes. Thank you!!!

eSRA Resources

eSRA Free Public Webinar

eSRA Free Public Webinar

April 24, 2018

This webinar will discuss why Investigator Site Systems should be assessed using the eCF eSRA (eSource-Readiness Assessment) tool, what the regulatory basis is for the tool, and how to access it. Updates to eSRA Rel2018.1 and the eSRA/eClinical Network process will be highlighted.

Date/Time: This Webinar is offered at 2 times in order to accommodate participants from around the world and to avoid different national holidays. 
Webinar A:  Thursday March 22 (concluded)
Webinar B:  Tuesday April 24 at UTC 0800 (UK 0900, Western Europe 1000, Eastern Europe 1100, India 1330, China, Singapore & Perth 1600, Japan 1700, Sydney 1800)

Click on title for more information

 

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eSRA (eSource Readiness Assessment) Handbook and Assessment Template

eSRA (eSource Readiness Assessment) Handbook and Assessment Template

Version 2018.1

This handbook provides needed information for

- Sites to complete an eSource-Readiness Assessment (eSRA) to self-assess their healthcare computerized systems (EHR/EMR) for readiness to originate or handle electronic data that could become part of a clinical research study.

- Sponsors/CROs to evaluate a completed eSRA from a site, to determine if data that originated in the site's healthcare computerized system complies with clinical research regulations

- Download the Handbook file and save to your computer. The instructions are in section 3 and the assessment is in section 5. Sites should complete the assessment and email it to their sponsors.

 

Click on title to get to the download screen.

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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)

Release 2018.1

eCF eSRA Release 2018.1 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan) and ICH (International). The eClinical Forum will continue to monitor new releases and updates of regulatory documents from these agencies to determine if the eSRA template questions should be updated.

Click on document title to download.

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eSRA Use is Growing!

eSRA Use is Growing!

Feb 2018 Statistics on use of eSRA around the globe

eClinical Forum has provided a free assessment tool for clinical research sites to self-assess their computerized systems for readiness to originate or handle data that could become part of a regulated clinical trial. This tool is called the "eSource-Readiness Assessment" or "eSRA" and has been available since August 2015. As of February 2018, it has been used by over 1140 sites in 47 countries.

Click on title to download complete statistics

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Report: Site Readiness for CR Source Data

Report: Site Readiness for CR Source Data

Summary of eSRA Responses: October 2015 through March 2018

Stay Tuned! We will be compiling and analyzing the eSRA responses from eSRA Release 1 (October 2015 through March 2018). Data will be presented in an anonymized and summarized form. We hope to identify areas for improvement within the e-Clinical arena.  We anticipate this report to be ready June 2018.

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