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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)

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

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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Technology Showcase Webinar: How can a modern CTMS help you to ensure successful trial execution

Succeeding with CTMS – how can a modern CTMS help you to ensure successful trial execution
Knowing how and when to use clinical trial management software/systems (CTMS) and how to integrate data from other eclinical systems can help ensure successful trial execution. This tech showcase will highlight what you can expect from a modern CTMS including successful integration ideas and techniques.

Presented by: Jan Klint Nielsen, BSI Business Systems Integration AG

Available to staff from eClinical Forum member companies only. For more information, please contact webmaster3@eclinicalforum.org 

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