In the current regulatory climate, sponsors should anticipate more FDA sponsor GCP inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site without relying on the “star performer.” Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of vendors, as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections of sponsor monitoring programs.
- Discuss BIMO Sponsor/CROs and monitors program
- Identify components of a sponsor monitoring system: Beyond SOPs
- Distinguish each component’s suggested elements
- Define adequate oversight of non-employee performers
- Identify other measures to ensure quality monitoring
- Evaluate gaps in monitoring systems
- Sponsor Senior Management
- Project Managers
- Clinical Research Associate Managers
- Quality Assurance and Compliance Professionals
- Clinical Research Associates
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#: 0778-0000-13-002-L01-P. Released: 1/13.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.