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
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