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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 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

Electronic Informed Consent Technology Showcase - An Excellent Event

Published on Wednesday, November 30, 2016

Electronic Informed Consent Technology Showcase - An Excellent Event

Event Feedback

Untitled 2 Electronic Informed Consent in clinical trials has been highlighted as a topic of interest at recent eClinical Forum meetings. The technology demonstration provided a good insight into the functional capabilities, business opportunities and challenges of eICF systems.
Our thanks go to Scott Askin, Novartis, Switzerland and to Eric Delente, DrugDev, USA who facilitated a very interesting webinar.
Slides used during the event can be downloaded by eCF members.

The session explored in detail:

  • How eICF can improve how we engage, manage and monitor patients involved in clinical trials
  • The change management challenges
  • How such Digital Technologies can make a significant difference
  • The functionality offered by one eICF system offered by Enforme Interactive/Drug Dev’s SecureConsent Application
  • Measured improvements in comprehension and process control
  • The steady growth in use and experience
  •  Best practices, business value and Regulatory acceptance
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