CCRP EXAM QBANK | 273 QUESTIONS AND ANSWERS
CCRP EXAM QBANK | 273 QUESTIONS AND ANSWERS
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
- Risks are reasonable in relation to anticipated benefits
- Selection of subjects is equitable
- Informed consent will be sought from subjects or LARs
- Informed consent will be documented
- There is adequate provision of monitoring
- 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 - Description of reasonably foreseeable risks
- Benefits
- Disclosure of alternative procedures or courses of treatment
- Confidentiality measures
- Compensation and treatments available if injury occurs
- contact information
- 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 - 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 - Relation of anticipated benefit is at least as favorable as that presented by alternative
approaches - 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 - Intervention presents experiences that are reasonable commensurate with normal medical and
living situations - Intervention is likely to yield generalizable knowledge that is vital
- 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
Who created the Belmont Report? Correct Ans ➡ National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research (at direction of National Research
Act 1974)
What are the 3 principles in the Belmont Report? Correct Ans ➡ 1) Respect for Persons:
informed consent required and individuals with diminished autonomy get special protections
2) Beneficence: maximize benefit to research while minimizing risk to subjects
3) Justice: one group of people shouldn’t assume risks for the benefit of another (equality and
diversity of participants)
In what order were historical declarations for human subjects protection released? Correct
Ans ➡ Nuremberg Code > Declaration of Helsinki > Belmont Report
At what reading level should ICFs be written? Correct Ans ➡ 6th-8th grade
What FDA guideline lists the basic elements of informed consent? Correct Ans ➡ 21 CFR
50 (50.25)
What are the additional elements of informed consent per FDA guidelines? (7) Correct Ans
➡ 1) Statement that treatment may involve unforseeable risks
2) Circumstances in which subject participation may be terminated
3) Additional costs to subject
4) Consequences of subject’s decision to withdraw
5) Statement that new findings will be provided to subject
6) # of subjects in study
7) clinicaltrials.gov statement (as applicable)
Who ultimately approves an ICF? Correct Ans ➡ IRB – sponsor can provide sample form
Describe the 2 most important points to consider when consenting patients (per 21 CFR 50)
Correct Ans ➡ 1) No person can participate without their or LAR consent (50.20)
2) Documentation of informed consent is required (50.27)
What are the 4 components of the consent process using a short form? Correct Ans ➡ 1)
Short form consent document stating all elements of ICF have been presented orally to pt/LAR
2) Oral presentation of required elements
3) IRB-approved summary of what is said
4) Witness present during presentation
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