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 2019 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. 

eSRA Resources

Determining if Data from Electronic Health Record Systems Can Be Trusted in a Clinical Trial Setting

Published on Tuesday, January 1, 2019

Determining if Data from Electronic Health Record Systems Can Be Trusted in a Clinical Trial Setting

Applied Clinical Trial's article on eCFs eSource-Readiness Assessment (eSRA)

Electronic Health Record (EHR) systems are being used increasingly by clinical investigative sites; and there is a growing expectation, by regulatory agencies, for clinical trial sponsors to verify that EHR systems comply with requirements to protect confidentiality and provide accurate and reliable data for the use in a regulated research environment. 

With the FDA’s recent guidance “Use of Electronic Health Record Data in Clinical Investigations” (July 2018), as well as the EMA reflection paper on eSource (June 2010), it is clear the expectation that sponsors evaluate the EHR systems that may provide data for their studies. However, identifying all global requirements for EHR systems can be a daunting task for sponsors, investigative sites and technology vendors.  To add to the complexity, sponsor companies have varied ways of assessing and documenting an EHR system’s readiness for use in clinical research, making it time consuming for sites to comply.

The eClinical Forum, a non-commercial, non-profit global organization with over 45 organizations active in clinical research, has established criteria to allow compliant use of EHR data in clinical trials. Their eSource Readiness Assessment (eSRA) checklist has been created with sponsors and research sites to simplify the self-assessment of EHR system use in clinical research. It is a standardized approach and free of charge. It allows sites to reuse their assessment across all their clinical trial sponsors.  It provides all users (clinical research sponsors, CROs, sites, regulators, technology vendors) with the ease of a common assessment that is solely based on regulatory guidance. eSRA has already been used in several thousand sites worldwide and is currently in its 2nd version. A 2019 update is planned.

For complete article, please see Applied Clinical Trial website: http://www.appliedclinicaltrialsonline.com/determining-if-data-electronic-health-record-systems-can-be-trusted-clinical-trial-setting

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