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Center for Immunization Research

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Basic GCP Workshop

This three-day workshop, leading to GCP certification for clinical vaccine trial site personnel, utilizes a design that is innovatively distinct from “off-the-shelf” GCP courses targeted for general audiences. We provide an applied “site-perspective” approach to GCP implementation, working closely with the sponsors to develop materials and exercises that are relevant to the clinical sites. Workshops are highly interactive and exercise-driven, enabling us to strategize solutions to complex case studies in a non-punitive environment. The team-based workshop is protocol driven, bringing GCP to life. Topics covered include:

  • Investigator responsibilities
  • Protocol compliance
  • Source documentation
  • Case report form completion
  • Safety reporting
  • Quality management
  • Human subjects protections and ethical concerns
  • Site development
  • Institutional review board responsibilities
  • Sponsor responsibilities
  • Subject recruitment
  • Investigational product management

Basic GCP

Advanced GCP

Clinical Vaccine Trials and GCP Online Course (for credit)

Comprehensive GCP Online Course (non-credit)