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  • Clinical Trials Audit Proof Monitoring Programs

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Friday - May 31, 2013 10:00 AM
  • End Time:
  • Friday - May 31, 2013 11:30 AM
  • Location:
  • Online
  • This clinical trial audit training will explain how to identify gaps and risks when preparing for regulatory inspections of sponsor monitoring programs by understanding the components of a clinical trial quality monitoring system.

    Why Should You Attend:

    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. In this Webinar 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.

    Areas Covered in the Seminar:

    - Discuss Sponsor 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.
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