CCRP Exam TestBank With 100% correct Answers

1. How many days does a sponsor have to report an emergency use of an IP to the FDA?: 5 working days 2. How many members must sit on an IRB?: 5 3. How long must an IRB retain records per 21 CFR 56?: 3 years after comple- tion of research 4. What are the criteria for IRB approval of research? (7): 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 5. Informed consent will be documented 6. There is adequate provision of monitoring 7. There is adequate provision to protect the privacy of subjects 5. How many days does an IRB have to report a change in registration information due to a change in chairperson or contact?: 90 days 6. How many days does an IRB have to inform the FDA that it is reviewing different types of FDA products?: 30 days 7. How often must an IRB renew it's registration?: 3 years 8. What are the 8 basic elements of informed consent per FDA guidelines?- : 1. Statement that the study involves research, purpose and expected duration, description of experimental procedures 2. Description of reasonably foreseeable risks 3. Benefits 4. Disclosure of alternative procedures or courses of treatment 5. Confidentiality measures 6. Compensation and treatments available if injury occurs 7. contact information 8. Participation is voluntary and subject may discontinue at any time 9. What are the criteria for involving children in minimal risk research? (2): 1. No greater than minimal risk 2. Assent from kid + consent from parent obtained 10. What are the criteria for involving children in greater than minimal risk research with prospect of benefit? (3): 1. Risks are justified by benefits 2. Relation of anticipated benefit is at least as favorable as that presented by alternative approaches 3. Assent + consent 11. What are the criteria for involving children in greater than minimal risk research with no direct benefit? (4): 1. Risks are minor increase over minimal risk 2. Intervention presents experiences that are reasonable commensurate with normal medical and living situations 3. Intervention is likely to yield generalizable knowledge that is vital 4. Assent + consent 12. Sponsors must report SAEs to the FDA within how many days of discov- ering the event?: 15 calendar days (21 CFR 312.32) 13. Investigators must report SAEs to a sponsor within how many days of discovering the event?: Immediately (21 CFR 312.64) 14. Sponsors must report what kind of serious events to the FDA within 15 calendar days? (4): 1) Serious and unexpected suspected adverse reactions 2) Findings from other studies that suggest a significant risk in humans 3) Findings from animal or in-vitro testing that suggest risks to humans 4) Increased rate of occurrence of serious suspected adverse reactions 15. Sponsors must submit Unanticipated Adverse Device Effects to the FDA within how many days?: 10 working days (21 CFR 812.15) 16. Investigators must submit Unanticipated Adverse Device Effects to the FDA within how many days?: 10 working days (21 CFR 812.15) 17. When was the Nuremberg Code issued?: 1947 18. What are the 10 points made in the Nuremberg Code?: 1) Voluntary in- formed consent should be obtained 2) Research should yield benefit to society 3) Research should be based on animal work 4) Avoid unnecessary suffering 5) Don't do research resulting in death or disabling injury 6) Risks should be justified by benefits 7) Proper prep and adequate facilities should be used 8) Conducted by scientifically qualified people 9) Subject can withdraw whenever 10) Researchers can end the study if risks are too great 19. When was the Declaration of Helsinki released?: 1964 20. Who developed the Declaration of Helsinki?: World Medical Association (WMA)