en-USen-GB

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

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

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

Applied Clinical Trials (English), PHARMSTAGE (Japanese)

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. eClinical Forum provides a free tool to assist sponsors and sites in deternining if their EHR systems are appropriate to source clinical research data.

This very important topic has been featured in 2 prominent industry magazines:

Applied Clinical Trials (English, December 2018)

PHARMSTAGE (Japanese, October 2019)

eSRA Slides suitable to present to your organization

eSRA Slides suitable to present to your organization

At recent eCF meetings we have discussed the eSource-Readiness Assessment (eSRA) and the desire that it is used widely by sponsors to assist their sites in assessing the appropriateness of their EHRsystems for providing data for clinical trials. At the eCF meeting at Janssen in Brussels in May 2019, Sumarni Oetringer and Martijn Griep presented a ppt presentation they had created to provide information for J&J … showing how eSRA can be used to save the sponsors and sites a lot of time and effort.  There has been a request to make this ppt deck available to all for use in presenting the case to use eSRA to your organization. Sumarni has modified it so that it is more general and not J&J-specific.

If you are a site and you some of your sponsors are not using eSRA, please pass this presentation on to them. If you are a sponsor or CRO and you are not (yet) using eSRA, please present this to those in your organization who are doing site assessments.

Thanks for spreading the word!  The more organizations that use eSRA, the more efficient and time-saving it becomes for all Sponsors, CROs and Sites.

Example of a completed eSRA V2019

Example of a completed eSRA V2019

This example has been anonymized from an actual site completed eSRA assessment. It provides an idea of what the eSRA team considers an appropriate level of commenting. The eSRA team provides no opinion or guidance on these answers -- this is an example only and not to be considered as endorsement for any system with similar eSRA assessment.

eSRA Use is Growing!

eSRA Use is Growing!

Feb 2018 Statistics on use of eSRA around the globe

eClinical Forum has provided a free assessment tool for clinical research sites to self-assess their computerized systems for readiness to originate or handle data that could become part of a regulated clinical trial. This tool is called the "eSource-Readiness Assessment" or "eSRA" and has been available since August 2015. As of February 2018, it has been used by over 1140 sites in 47 countries.

Click on title to download complete statistics

RSS
12

Theme picker

This form...