AACVPR CCRP ACTUAL EXAM SOLVED
QUESTIONS COMPLETE STUDY GUIDE
●● How many members must sit on an IRB?
Answer: 5 members
●● How long must an IRB retain records per 21 CFR 56?
Answer: 3 years after completion of a research study
●● What are the criteria for an IRB approval of a research study? (7)
Answer: a. Risks to subjects are minimized
b. Risks are reasonable in relation to anticipated benefits
i. Anticipated benefits should always be primary.
c. Selection of subjects is equitable
d. Informed consent will be sought from subjects and LARs
e. Informed consent will be documented
f. There is adequate provision of monitoring
i. Monitor visits
g. There is adequate provision to protect the privacy of subjects
i. HIPPA
,●● 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 to report
●● How many days does an IRB have to inform the FDA that it is (IRB)
reviewing different types of FDA products?
Answer: 30 days to inform
●● How often must an IRB renew its registration?
Answer: Every 3 years
●● What are the (8) basic elements of an informed consent per FDA
guidelines?
Answer: a. A statement that the study:
i. Involves research
ii. The purpose
iii. The expected duration
iv. A description of experimental procedures
b. A description of reasonably foreseeable risks
i. Potential risks
c. The benefits
d. A disclosure of alternative procedures or courses of treatment
i. Provide information of other alternatives for a condition.
,e. Confidentiality measures
i. HIPPA
f. Compensation and treatments available if injury occurs
g. Contact Information
i. PI
ii. Sponsor
iii. IRB
h. Participation is voluntary and subject may discontinue at any time.
●● What are the criteria for involving children in minimal risk research
(not a high-risk research)?
Answer: a. No greater than minimal risk (research is not high in risks)
b. Assent form from child obtained
c. Consent form from parent/LAR obtained
●● What are the criteria for involving children in greater than minimal
risk research (high in risks) with prospect of benefit?
Answer: a. Risks are justified by the benefits
i. The benefits outweigh the risks
b. Relation of anticipated benefits is at least as favorable as that
presented by alternative approaches.
i. The benefits of the research are just as good as the alternative
procedures and treatments.
, c. Assent form from child obtained
d. Consent form from parent/LAR obtained
●● What are the criteria for involving children in greater than minimal
risk research (high in risks) with no direct benefit?
Answer: a. Risks are minor increase over minimal risk
b. Intervention presents experiences that are reasonable commensurate
(equal) with normal medical and living situations
c. Intervention is likely to yield generalizable knowledge that is vital
i. Research will provide knowledge that is vital to the community
d. Assent form from child obtained
e. Consent form from parent/LAR obtained
●● Sponsor must report SAEs to the FDA within how many days of
discovering the event?
Answer: Report in 15 calendar days per 21 CFR 312.32
●● Investigators must report SAEs to the SPONSOR within how many
days of discovering the event?
Answer: Report immediately or 24 hours per 21 CFR 312.64
●● Sponsor must report what kind of serious events to the FDA within
15 calendar days?
QUESTIONS COMPLETE STUDY GUIDE
●● How many members must sit on an IRB?
Answer: 5 members
●● How long must an IRB retain records per 21 CFR 56?
Answer: 3 years after completion of a research study
●● What are the criteria for an IRB approval of a research study? (7)
Answer: a. Risks to subjects are minimized
b. Risks are reasonable in relation to anticipated benefits
i. Anticipated benefits should always be primary.
c. Selection of subjects is equitable
d. Informed consent will be sought from subjects and LARs
e. Informed consent will be documented
f. There is adequate provision of monitoring
i. Monitor visits
g. There is adequate provision to protect the privacy of subjects
i. HIPPA
,●● 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 to report
●● How many days does an IRB have to inform the FDA that it is (IRB)
reviewing different types of FDA products?
Answer: 30 days to inform
●● How often must an IRB renew its registration?
Answer: Every 3 years
●● What are the (8) basic elements of an informed consent per FDA
guidelines?
Answer: a. A statement that the study:
i. Involves research
ii. The purpose
iii. The expected duration
iv. A description of experimental procedures
b. A description of reasonably foreseeable risks
i. Potential risks
c. The benefits
d. A disclosure of alternative procedures or courses of treatment
i. Provide information of other alternatives for a condition.
,e. Confidentiality measures
i. HIPPA
f. Compensation and treatments available if injury occurs
g. Contact Information
i. PI
ii. Sponsor
iii. IRB
h. Participation is voluntary and subject may discontinue at any time.
●● What are the criteria for involving children in minimal risk research
(not a high-risk research)?
Answer: a. No greater than minimal risk (research is not high in risks)
b. Assent form from child obtained
c. Consent form from parent/LAR obtained
●● What are the criteria for involving children in greater than minimal
risk research (high in risks) with prospect of benefit?
Answer: a. Risks are justified by the benefits
i. The benefits outweigh the risks
b. Relation of anticipated benefits is at least as favorable as that
presented by alternative approaches.
i. The benefits of the research are just as good as the alternative
procedures and treatments.
, c. Assent form from child obtained
d. Consent form from parent/LAR obtained
●● What are the criteria for involving children in greater than minimal
risk research (high in risks) with no direct benefit?
Answer: a. Risks are minor increase over minimal risk
b. Intervention presents experiences that are reasonable commensurate
(equal) with normal medical and living situations
c. Intervention is likely to yield generalizable knowledge that is vital
i. Research will provide knowledge that is vital to the community
d. Assent form from child obtained
e. Consent form from parent/LAR obtained
●● Sponsor must report SAEs to the FDA within how many days of
discovering the event?
Answer: Report in 15 calendar days per 21 CFR 312.32
●● Investigators must report SAEs to the SPONSOR within how many
days of discovering the event?
Answer: Report immediately or 24 hours per 21 CFR 312.64
●● Sponsor must report what kind of serious events to the FDA within
15 calendar days?
