A Quality Systems approach to establishing and maintaining regulatory compliance allows Sponsors to better leverage their resources and Clinical Investigators to meet their obligations for clinical research oversight. This course will review the elements of a Quality System at the Clinical Investigator Site and how it functions to proactively control site-level noncompliance.
- Discuss an overview of Sponsor and Clinical Investigator responsibilities
- Explain how to identify the active elements of a functional quality system at the clinical research site
- Discuss how implementation of a Quality System can assist in the requirements for meeting obligations of Sponsors and Clinical Investigators
- Determine how Quality System overlaps with FDA Guidance
- Examine recent compliance concerns and how applying the Quality System framework at the site level can address them
- Directors of Clinical Operations at Clinical Research Sites
- Clinical Investigators (PIs)
- Clinical Research Coordinators (CRCs)
- Clinical Research Associates (CRAs)
- Project Managers
- All Clinical Research Personnel involved in selecting and/or overseeing clinical research sites
Elizabeth Ronk Nelson, MPH
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2 hours; 12:30 - 2:30 p.m. Eastern
April 12, 2011
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.