CCRP EXAM 273 COMPREHENSIVE STUDY
QUESTIONS AND ANSWERS
◉ How many members must sit on an IRB?
Answer: 5
◉ How long must an IRB retain records per 21 CFR 56?
Answer: 3 years after completion of research
◉ What are the criteria for IRB approval of research? (7)
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?
Answer: 90 days
,◉ How many days does an IRB have to inform the FDA that it is
reviewing different types of FDA products?
Answer: 30 days
◉ How often must an IRB renew it's registration?
Answer: 3 years
◉ What are the 8 basic elements of informed consent per FDA
guidelines?
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)
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)
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)
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?
Answer: 15 calendar days (21 CFR 312.32)
◉ Investigators must report SAEs to a sponsor within how many
days of discovering the event?
, Answer: Immediately (21 CFR 312.64)
◉ Sponsors must report what kind of serious events to the FDA
within 15 calendar days? (4)
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?
Answer: 10 working days (21 CFR 812.15)
◉ Investigators must submit Unanticipated Adverse Device Effects
to the FDA within how many days?
Answer: 10 working days (21 CFR 812.15)
◉ When was the Nuremberg Code issued?
Answer: 1947
QUESTIONS AND ANSWERS
◉ How many members must sit on an IRB?
Answer: 5
◉ How long must an IRB retain records per 21 CFR 56?
Answer: 3 years after completion of research
◉ What are the criteria for IRB approval of research? (7)
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?
Answer: 90 days
,◉ How many days does an IRB have to inform the FDA that it is
reviewing different types of FDA products?
Answer: 30 days
◉ How often must an IRB renew it's registration?
Answer: 3 years
◉ What are the 8 basic elements of informed consent per FDA
guidelines?
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)
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)
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)
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?
Answer: 15 calendar days (21 CFR 312.32)
◉ Investigators must report SAEs to a sponsor within how many
days of discovering the event?
, Answer: Immediately (21 CFR 312.64)
◉ Sponsors must report what kind of serious events to the FDA
within 15 calendar days? (4)
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?
Answer: 10 working days (21 CFR 812.15)
◉ Investigators must submit Unanticipated Adverse Device Effects
to the FDA within how many days?
Answer: 10 working days (21 CFR 812.15)
◉ When was the Nuremberg Code issued?
Answer: 1947
