#Barnett
Purchase the recording of a web seminar you have attended in the past and SAVE 50%! Contact Barnett Customer Service for details: +1 781.972.5400 or toll-free in the U.S. at 800.856.2556.
Web Seminar Archives provided through Barnett’s Learning Management System (Single User access) or by electronic file transfer (Site License).
Site license archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.
Bulk Archive access is available via Barnett’s Training Subscription. Click here to learn more.
Archive: Use of Electronic Health Record Data in Clinical Investigations
Course Description
The FDA recognizes Electronic Health Records (EHRs) as data originators and in many cases, source documentation, which therefore subjects them to inspection. In its draft guidance for the Use of Electronic Health Record Data in Clinical Trials, the FDA expands upon prior guidance and provides its recommendations on the use of EHRs as source, and also outlines the responsibilities for ensuring quality and integrity of EHR data. As such, EHRs should be able to be obtained from multiple sources, they should be shareable, interoperable, and accessible to authorized parties. This web seminar will address recommendations for the use of EHRs as source data in clinical trials.
Video Preview
Learning Objectives
- Describe the responsibilities and processes for assessing the validity, reliability, and integrity of EHR source data
- Review the FDA’s intentions to assess the compliance of EHRs with 21 CFR 11
- Evaluate best practices for using EHRs in clinical research
- Describe interoperability in EHR use
- Discuss the impact on recommendations for research conducted outside the U.S.
Who Should Attend
- Clinical Research Associates
- Project Managers
- Principal Investigators
- Clinical Research Coordinators
- Regulatory Affairs Professionals
- Academic Medical Center and Research Institution Professionals supporting clinical research
- Personnel responsible for ensuring compliance with GCP regulations
Instructor
Elizabeth Ronk Nelson, M.P.H.
Click here for complete trainer biographies
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.