The eSOURCE-READINESS ASSESSMENT TOOL (eSRA)

The tool 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 trials. An eClinical Forum team, comprised of CRAs and Data Managers from different clinical research sponsor organizations and CROs and representatives from sites, has produced the "eSource-Readiness Assessment", otherwise known as "eSRA" for sites to perform a self-assessment of their computerized system's ability to be compliant with clinical research regulations.

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 directly from the site's healthcare system, but are 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.

The eSRA Questionnaire Version 2024 can be downloaded as part of the eSRA Handbook below.  (This version incorporates changes based on the EMA Guideline on computerised systems and electronic data in clinical trials.)

Notice to those intending to include eSRA in their own materials: Copyrighted by the eClinical Forum 2024. The eClinical Forum keeps all rights of this material. Please see the License for Fair Use in the eSRA Handbook and “Implementing eSRA” Guide. We welcome eSRA to be used in other formats, however, it is required that eSRA text be used exactly, that all eSRA questions are included, that your use of eSRA is updated when eCF eSRA is updated, and that eClinical Forum is notified in writing and credited. By using these materials, you acknowledge the terms and conditions for use.  The eClinical Forum is only responsible for the eSRA materials as distributed via the eClinical Forum website. If using the eCF form, downloaded from this website, in it's original format, there is no need to notify eCF.

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.

Sponsors & CROS -- Please take our very brief survey regarding how you are using eSRA.  This will help us improve eSRA. Survey link: eCF eSRA Survey (eclinicalforum.org) THANK YOU!!!

Do we keep a list of sites that have completed eSRAs?

We have frequently been asked if we can provide a list of which sites have already completed an eSRA. Due to privacy laws in different countries, eClinical Forum does not keep such a list. We supply the eSRA questionnaire, free of charge, to anyone who wants to use it. We encourage sponsors to keep a list for themselves of which sites they have received a completed eSRA from. We encourage sites to store their completed eSRA in a central location (such as their IT department) so that other groups within the same organization / using the same electronic healthcare system, can use the completed eSRA as a basis to complete their own eSRA.

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eSRA Maintenance

Published on 01 March 2018

eSRA Maintenance

Self-Evaluating the GCP Compliance of Systems Holding Source Data

eSRA Maintenance Working Group

eSRA (eSource-Readiness Assessment) is a questionnaire used by sites to self-evaluate their electronic systems that may originate or manage data for clinical research.  It has been provided, free of charge, since 2016 and is updated annually, based on updates to the underlying regulatory documents and new interpretations from regulatory authorities.  It was developed and continues to be updated, with extensive participation of global biopharma, CROs, technology providers, academia and with regulatory review.

It is important that site systems that will supply source data for clinical research be designed and maintained to meet regulatory requirements. Sponsors ultimately bear the responsibility for ensuring that data harvested from these systems are acceptable, and investigators are frequently being asked to complete sponsor-specific assessments of their electronic record systems.  The eSRA project has developed a free tool that vendors and sites can use to quickly and easily evaluate their systems once for all sponsors, CROs, and regulators.

The tool offers a series of questions based on FDA, EMA and PMDA regulations and guidances. A site can quickly identify if its system and/or processes are compliant with research regulations or if additional processes need to be put into place. Using this assessment tool will enable sites to quickly provide the information needed by sponsors on GCP compliance of systems holding source data and will enable sponsors to evaluate and manage risk.

The eSRA Maintenance Working Group welcomes all feedback/questions on any of the eSRA materials offered via their web page (www.eclinicalforum.org/esra).  Please send feedback to esra@eclinicalforum.org.  All feedback/questions will be responded to. 

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