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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 Template Version 2019 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

eSRA (eSource Readiness Assessment) Handbook and Assessment Template

eSRA (eSource Readiness Assessment) Handbook and Assessment Template

Version 2019

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.

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Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

Release 2019

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.

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Determining if Data from Electronic Health Record Systems Can Be Trusted in a Clinical Trial Setting

Determining if Data from Electronic Health Record Systems Can Be Trusted in a Clinical Trial Setting

Applied Clinical Trial's article on eCFs eSource-Readiness Assessment (eSRA)

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.

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Investigator Site Survey .. Please Participate

Investigator Site Survey .. Please Participate

Partnering for Success

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...

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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.

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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.

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