Quality assurance is defined as a “systematic and independent examination of trial-related activities and documents” that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This course will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).
- Discuss how QA differs from QC and who is responsible for each
- Determine who gets audited and factors and metrics for assessing when or why to audit
- Discuss guidelines on how the FDA trains its investigators to audit Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs)
- Review recent noncompliance trends and regulatory focus for Sites, Sponsors, and IRBs
- Clinical Quality Assurance Auditors
- Clinical Quality and Compliance Professionals
- Clinical Research Associates (CRAs)
- Project Managers
- Medical Monitors
- Regulatory Affairs Professionals
- Clinical Research Coordinators (CRCs)
- Clinical Investigators (PIs)
- IRB Administrators and Members
Elizabeth Ronk Nelson, MPH
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2 hours; 1:00 - 3:00 p.m. Eastern
August 26, 2010
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.