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1. The responsibility for ensuring that the investi-gator understands a clinical trial lies with which individual/or organization? A) FDA B) IRB C) Sponsor D) Coordinator 2. What is the minimum number of IRB Members? A) 3 B) 5 C) 6 D) 10 C) Sponsor B) 5 3. A significant risk device is defined as an investiga- D ) All of the above tion