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

Investigator Site Survey .. Please Participate

Published on Wednesday, January 25, 2017

Investigator Site Survey .. Please Participate

Partnering for Success

The eClinical Forum is a non-commercial group working to improve the use of technology in clinical research. One of the objectives of the eClinical Forum is to increase the involvement of site staff in defining current and future requirements of technology systems and processes used in clinical research.

The eCF Site Survey survey is open to all site staff involved in clinical trials. The information collected will be used to help us continue to improve the way clinical trial systems and processes are provided and used. You can read about the results of previous site surveys in 2001 and 2009 here.

By participating in this survey, you will help us to better understand the experience and needs of site staff with clinical trial systems and processes.

This is a voluntary survey and is not required to complete an eSource-Readiness Assessment (eSRA).

Go to the Survey...


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