3. Sponsor

• Sponsor
• 3.1 Trial design
• 3.2 Resources
• 3.3 Allocation of activitie
• 3.4 Qualification and training
• 3.3 Allocation of activitie copy
• 3.5 Financing
• 3.6 Agreements
• 3.7 Investigator selection
• 3.8 Communication with IRB/IEC and regulatory authority(ies)
• 3.9 Sponsor oversight
• 3.10 Quality management
• 3.11 Quality assurance and quality control
• 3.12 Noncompliance
• 3.13 Safety assessment and reporting
• 3.14 Insurance/indemnification/compensation to participants and investigators
• 3.15 Investigational Product(s)
• 3.16 Data and records
• 3.17    Reports