Good Clinical Practice training serves as the pre-requisite for any individual participating in clinical research at any level. Advantage Clinical is proud to offer industry recognized GCP training in our comprehensive custom learning management system.
Advantage Clinical’s Good Clinical Practice series goes beyond the guidance and provides students with real world applications and skills to apply GCP in their roles as clinical research professionals.
Within this GCP course we include role-based course branching, where students can focus on how GCP is applied to their particular role as a clinical research professional at your organization. This course includes pathways for:
Principal and Sub-Investigators
Clinical Research Coordinators
Clinical Support Staff
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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