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CCRP Exam Questions and Complete Solutions Graded A+
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CCRP Exam Questions and Complete Solutions Graded A+
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CCRP ExamQuestions and
Complete Solutions
Graded A+
Denning [Date] [Course title]
,How many days does a sponsor have to report an emergency use of an IP to the FDA? - Correct Ans: 5
working days
How many members must sit on an IRB? - Correct Ans: 5
How long must an IRB retain records per 21 CFR 56? - Correct Ans: 3 years after completion of research
What are the criteria for IRB approval of research? (7) - Correct Ans: 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 Ans: 90 days
How many days does an IRB have to inform the FDA that it is reviewing different types of FDA products?
- Correct Ans: 30 days
How often must an IRB renew it's registration? - Correct Ans: 3 years
What are the 8 basic elements of informed consent per FDA guidelines? - Correct Ans: 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 Ans: 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 Ans: 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 Ans: 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 Ans: 15
calendar days (21 CFR 312.32)
Investigators must report SAEs to a sponsor within how many days of discovering the event? - Correct
Ans: Immediately (21 CFR 312.64)
Sponsors must report what kind of serious events to the FDA within 15 calendar days? (4) - Correct Ans:
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 Ans: 10 working days (21 CFR 812.15)
Investigators must submit Unanticipated Adverse Device Effects to the FDA within how many days? -
Correct Ans: 10 working days (21 CFR 812.15)
When was the Nuremberg Code issued? - Correct Ans: 1947
What are the 10 points made in the Nuremberg Code? - Correct Ans: 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 Ans: 1964
Who developed the Declaration of Helsinki? - Correct Ans: World Medical Association (WMA)
What is the Declaration of Helsinki? - Correct Ans: Document that laid out general principles physicians
should follow to conduct research with humans, based on Nuremberg Code. First effort of medical
community to regulate itself
When was the Belmont Report released? - Correct Ans: 1979
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