This document is written specifically for Sponsors to assist them in determining how to fit eCF's eSource-Readiness Assessment (eSRA) into their procedures for determining if data which originated on a  site's electronic health record system is suitable for use in their clinical trial. It shows the benefits of using a common assessment tool, provides suggestions for implementing eSRA, and shows a mapping of eSRA questions to regulatory authority statements/expectations.

This is the ONE FILE that you need to perform an eSRA EMR/EHR Assessment.

- Sites should complete an eSource-Readiness Assessment (eSRA) to self-assess their healthcare computerized systems (EHR/EMR) for readiness to originate or handle electronic data that could become part of a clinical research study.

- Sponsors/CROs will find useful information in the Handbook in order to evaluate a completed eSRA from a site, to determine if data that originated in the site's healthcare computerized system complies with clinical research regulations

- Download the Handbook file and save to your computer. The instructions are in section 3 and the assessment is in section 5. Sites should complete the assessment and email it to their sponsors.

Click on title to get to the download screen.

eCF eSRA Release 2019 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan) and ICH (International). The eClinical Forum will continue to monitor new releases and updates of regulatory documents from these agencies to determine if the eSRA template questions should be updated.

Click on document title to download.

Applied Clinical Trials has published an article on the eCF eSource-Readiness Assessment (eSRA). eSRA is a list of questions, based on regulation and guidance from FDA, EMA, PMDA, and ICH for Clinical Research sites to self-assess their readiness to provide data from their electronic health records systems. This data may be electronically supplied to sponsors, or manually entered into a sponsor system, however if it originates in a healthcare system, then sponsors are responsible for assessing that these systems are appropriate.

The ongoing Investigator Site Survey survey is open to all site staff involved in clinical trials. 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 not eSRA -- it is a voluntary survey -- it is not an assessment.  (If you are looking for eSRA, please download the Handbook below).  GO TO THE SURVEY. Expand the article to read more...

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.

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.

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