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 Questionnaire 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 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. 

eSRA Resources

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

Published on Tuesday, January 17, 2017

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

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In November 17, 2016, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released E6 R2 which tries to address some of major developments in technology, medical breakthroughs and business processes – taking into account unprecedented yet justified expectations by regulators, patients, investigators and caregivers.

The eCF webinar explored what was removed and discussed some of the opportunities and challenges presented by additions to the E6 text:

  • How to eliminate sponsor control over Investigator entries/Source data? Where did the contemporaneous investigator copy go and should we forget all about it?
  • How to develop and document risk-based approaches to monitoring in order to protect reliability of trial results (Data Integrity)? How to develop monitoring plans which describe the strategy, methods, responsibilities, and requirements for monitoring the trial?
  • CSV formally makes its way into GCP in a more prescriptive manner than ever before – too late, too little?

Slides used during the event can be downloaded by eCF members from the Members area of the website.

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