Sponsor
- Scope, Definitions and Checklists - 1.1
- Protocol - 1.2
- Informed Consent - 1.3
- Safety - 1.4
- Study Oversight - 1.5
- Study Documentation - 1.6
- Training and Qualifications - 1.7
- Investigational Medicinal Product (IMP) - 1.8
- Authorities - Submission, Approval and Notifications - 1.9
- Quality and Risk Management - 1.10
- Advanced Therapies - 1.11
- Data Capture and Management - 1.12
- Agreements - 1.13
- Monitoring 1.14
- Clinical Support - 1.15
