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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 2020 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

Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

Published on Tuesday, January 1, 2019

Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

Applied Clinical Trials (English), PHARMSTAGE (Japanese)

Applied Clinical Trials (English, December 2018) has published an article on the eCF eSource-Readiness Assessment (eSRA). eSRA is a list of questions, based on regulation and guidance from FDA, EMA, PMDA, and ICH for Clinical Research sites to self-assess their readiness to provide data from their electronic health records systems. This data may be electronically supplied to sponsors, or manually entered into a sponsor system, however if it originates in a healthcare system, then sponsors are responsible for assessing that these systems are appropriate.

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

PHARMSTAGE (Japanese, October 2019) has published an article titled “Assessment of Reliability of Electronic Health Records Data Used in Clinical Trials”. It is a six-page article to discuss global regulations on EHR data, describe what eSRA is and how it is used.

月刊PHARMSTAGE 2019年10月号に「電子カルテのデータを治験に利用するための信頼性の判定」というタイトルでeSRAを紹介しました。6ページの記事で、グローバルの電子カルテのデータに関する規制を解説し、eSRAとは何か、どのように利用されているか、を記載しています。

https://www.gijutu.co.jp/doc/magazine/p_2019_10.htm

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