CCRP EXAM QBANK | 273 QUESTIONS AND ANSWERS

CCRP EXAM QBANK | 273 QUESTIONS AND ANSWERS
Question : How many days does a sponsor have to report an
emergency use of an IP to the FDA?
CORRECT ANSWER: 5 working days
Question : How many members must sit on an IRB?
CORRECT ANSWER: 5
Question : How long must an IRB retain records per 21 CFR
56?
CORRECT ANSWER: 3 years after completion of research
Question : What are the criteria for IRB approval of research?
(7)
CORRECT ANSWER: 1. Risks to subjects are minimized
2. Risks are reasonable in relation to anticipated benefits
3. Selection of subjects is equitable
4. Informed consent will be sought from subjects or LARs

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