Sponsors & CROs -- Please take a few minutes to complete this brief survey regarding how your company reviews site healthcare systems. We would like the input of every company whether you are using eSRA or your own assessment or not assessing at all.

https://www.surveymonkey.com/r/Site_System_Assessment_Survey

The link/survey will only be active until the end of May 2019, but we encourage you to complete the survey before Friday, February 22 2019, as we need the information to improve the eSRA Version 2019 which will be available the first week of March. Responses after Feb 22, 2019 will be considered for the 2020 version.

Sites -- If you would like to provide feedback for the eSRA V2019, please describe your feedback in an email to esra@eclinicalforum.org 

Thank you in advance for your help!

eClinical Forum eSRA Team (comprised of members from Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, OmniComm, Pfizer)

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.

We are proud to announce an updated release of the eSRA (eSource Readiness Assessment) Handbook and Assessment Form. It is provided free on this website via the "eSRA" tab. This Version 2018.1 is an update, based on updates to FDA, EMA, PMDA and ICH regulatory documents. We encourage all Sponsors to use this assessment to assist in determining if data that originated in an investigator site system is suitable for inclusion in a clinical trial. We encourage all Investigator Sites to use this assessment tool and provide the resulting report to all Sponsors they are working with, thus avoiding the need to complete different assessments for each Sponsor. Full details of what this valuable tool provides can be found in the eSRA Handbook.

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.

eSRA V2019 is coming (end of Feb 2019) -- we are looking for CR Sites or eCF Member Sponsors & CROs to join the eSRA team in reviewing changes for the 2019 version! Please contact eSRA@eclinicalforum.org if you are interested.

Click on title to get to the download screen.

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...

The webinar provided an overview of eSRA 2018.1, including: 1) EHR as eSource for Clinical Trials, 2) Regulations and Guidelines used as a basis for eSRA questions, 3) eSRA V2018.1, 4) eSRA -- The Future

Click on the title above to get to the download area.

eCF eSRA Release 2018.1 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.

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.

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