This course includes over twenty-five tools and resources to assist in starting and staying prepared for a regulatory inspection including:
Audience:
Primary: Clinical Research Professionals involved in trials subject to regulatory inspections
Secondary: All Clinical Research Personnel
Knowledge level (basic, intermediate, advanced): Basic
Core Competencies:
Ethical and Participant Safety Concerns
Clinical Trial Operations (GCPs)
Study and Site Management
Product Development and Regulation
Activities Included:
Inspection Readiness: Best Practices for Managing Clinical Trial Inspections (No Contact Hours)
Evaluation