SOCRA Certification Questions and Answers Update

SOCRA Certification Questions and Answers Update
Question : 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 : What is the minimum number of IRB Members?
A) 3
B) 5
C) 6
D) 10
Correct answer: B) 5
Question : A significant risk device is defined as an
investigational device that is:
A) Intended as an implant and presents a potential for serious
risk to the health, safety, or welfare of a subject
B) Purported or represented to be for a use in supporting or
sustaining human life and presents a potential risk to the
health, safety, or welfare of a subject
C) For a use of substantial importance in diagnosing, curing,
mitigating, or treating disease, or otherwise preventing
impairment of human health and presents a potential for
serious risk to the health, safety, or welfare of a subject.
D) All the above
Correct answer: D ) All of the above

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