CCRP WRITTEN EXAM.

CCRP WRITTEN EXAM. How many days does a sponsor have to report an emergency use of an IP to the FDA? - correct answer 5 working days How many members must sit on an IRB? - correct answer 5 How long must an IRB retain records per 21 CFR 56? - correct answer 3 years after completion of research 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 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? - correct answer 90 days How many days does an IRB have to inform the FDA that it is reviewing different types of FDA products? - correct answer 30 days How often must an IRB renew it's registration? - correct answer 3 years What are the 8 basic elements of informed consent per FDA guidelines? - correct answer 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 What are the criteria for involving children in minimal risk research? (2) - correct answer 1. No greater than minimal risk 2. Assent from kid + consent from parent obtained What are the criteria for involving children in greater than minimal risk research with prospect of benefit? (3) - correct answer 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 What are the criteria for involving children in greater than minimal risk research with no direct benefit? (4) - correct answer 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 Sponsors must report SAEs to the FDA within how many days of discovering the event? - correct answer 15 calendar days (21 CFR 312.32) Investigators must report SAEs to a sponsor within how many days of discovering the event? - correct answer Immediately (21 CFR 312.64) Sponsors must report what kind of serious events to the FDA within 15 calendar days? (4) - correct answer 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 Sponsors must submit Unanticipated Adverse Device Effects to the FDA within how many days? - correct answer 10 working days (21 CFR 812.15) Investigators must submit Unanticipated Adverse Device Effects to the FDA within how many days? - correct answer 10 working days (21 CFR 812.15) When was the Nuremberg Code issued? - correct answer 1947 What are the 10 points made in the Nuremberg Code? - correct answer 1) Voluntary informed 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 When was the Declaration of Helsinki released? - correct answer 1964 Who developed the Declaration of Helsinki? - correct answer World Medical Association (WMA)