Presenter:  Kelley Olree, Study Manager – Pfizer, and eClinical Forum eSRA Team

This webinar will discuss:

• What the Sponsor’s responsibility is regarding using data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities
• Benefits of all sites and all sponsors and all CROs using a common assessment tool
• The eClinical Forum, a non-profit, non-commercial discussion/action group comprised of members of the Pharmaceutical and Clinical Research Services industry, along with sites and academia, have developed a regulatory-based assessment tool for clinical research sites to determine if their computer system (EHR, EMR, etc) is appropriate to hold regulated clinical trial data. It has been available for free for over 4 years and is currently being used around the globe by many sponsors and thousands of sites.
• The eClinical Forum’s free “eSource-Readiness Assessment” (eSRA) that assists the sponsor/site in determining if the site system is appropriate for sourcing clinical research records
• How a Sponsor/CRO can incorporate eSRA into their processes

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.

On 25-Feb-2020, Kelley Olree of Pfizer and eClinical Forum's eSRA Team, presented a very informative and insightful webinar on “Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool”. One participant sent us a note following the webinar "Let me congratulate you for the eSRA Form and the webcast shared yesterday. I’m pretty sure it will become an international standard."

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.

While several additional regulatory documents were mapped to the eSRA questions, they did not significantly change eSRA between V2019 and V2020. No questions were added or deleted. Some question text were modified to improve clarity. Please download the file showing each question with it's change.

eCF eSRA Release 2020 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan), CMPS (China) 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.

Electronic Health Record (EHR) systems are being used increasingly by clinical investigative sites; and there is a growing expectation, by regulatory agencies, for clinical trial sponsors to verify that EHR systems comply with requirements to protect confidentiality and provide accurate and reliable data for the use in a regulated research environment. eClinical Forum provides a free tool to assist sponsors and sites in deternining if their EHR systems are appropriate to source clinical research data.

This very important topic has been featured in 2 prominent industry magazines:

Applied Clinical Trials (English, December 2018)

PHARMSTAGE (Japanese, October 2019)

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...