2. Investigator

• 2.1 Qualifications and training
• 2.2 Resources copy
• 2.3 Responsibilities
• 2.4 Communication with IRB/IEC
• 2.5 Compliance with Protocol
• 2.6 Premature termination or suspension of a trial
• 2.7 Participant medical care and safety reporting
• 2.8 Informed consent of trial participants
• 2.9 End of participation in a clinical trial
• 2.10 Investigational product management
• 2.11 Randomisation procedures and unblinding
• 2.12 Records
• 2.13 Reports