SOCRA QUESTIONS AND ANSWERS

SOCRA QUESTIONS AND ANSWERS
Question 1: The responsibility for ensuring that the investigator
understands a clinical trial lies with which individual/or
organization?
A) FDA
B) IRB
C) Sponsor
D) Coordinator
CORRECT ANSWER: C) Sponsor
Question 2: What is the minimum number of IRB Members?
A) 3
B) 5
C) 6
D) 10
CORRECT ANSWER: B) 5
A significant risk device is defined as an investigational device
that is:

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