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