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.

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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

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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.

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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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Stay Tuned! We will be compiling and analyzing the eSRA responses from eSRA Release 1 (October 2015 through March 2018). Data will be presented in an anonymized and summarized form. We hope to identify areas for improvement within the e-Clinical arena.  We anticipate this report to be ready June 2018.

The Dutch Clinical Trial Foundation (DCTF) evaluate the use of eSRA for the validation of electronic health record (EHR) systems used at clinical research sites within the Netherlands. The group consists of representatives from several pharmaceutical companies, CROs and hospitals. Expand the article to learn more...