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 quality assurance differs from quality control 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
- Project Managers
- Medical Monitors
- Regulatory Affairs Professionals
- Clinical Research Coordinators
- Clinical Principal Investigators
- IRB Administrators and Members
Elizabeth Ronk Nelson, M.P.H.
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-12-019-L01-P. Released: 2/12.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.