Advantage Clinical’s Good Clinical Practice series for sponsors and CROs goes beyond the guidance, providing students with real world applications and skills to apply GCP in their roles at your organization.
Advantage Clinical’s GCP programs include variants for sites, sponsors and CROs. Each of our GCP courses alsoinclude a corresponding refresher course to save your team time in staying abreast of GCP requirements.
Within each of our GCP courses we include role based course branching, where students can focus onhow GCP applies to their particular role as a clinical research professional at your organization includingcourse pathways for:
Module and Content Breakdown
- What is Good Clinical Practice
- History and Evolution
- ICH Parties and Goals of International Harmonization
- Why is GCP needed?
- Key Objectives
- Components of GCP
- Principles of GCP
- Institutional Review Board Responsibilities
- Investigator Responsibilities
- Sponsor Responsibilities
- Monitoring and Safety
- Clinical Trial Protocols and Amendments
- Essential Documents
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. TransCelerate Biopharma is an industry body representing all of the major pharmaceutical and medical device trial sponsors.
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