CCRP Exam Graded A+

CCRP Exam Graded A+ How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANS5 working days How many members must sit on an IRB? - ANS5 How long must an IRB retain records per 21 CFR 56? - ANS3 years after completion of research What are the criteria for IRB approval of research? (7) - ANS1. 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 5. Informed consent will be documented 6. There is adequate provision of monitoring 7. There is adequate provision to protect the privacy of subjects How many days does an IRB have to report a change in registration information due to a change in chairperson or contact? - ANS90 days How many days does an IRB have to inform the FDA that it is reviewing different types of FDA products? - ANS30 days How often must an IRB renew it's registration? - ANS3 years What are the 8 basic elements of informed consent per