CCRP Exam 2027 Questions and Answers | 100% Correct Answers | Graded A+

CCRP Exam 2027 Questions and Answers | 100% Correct
Answers | Graded A+

Question 1.
How many members must sit on an IRB?

Correct Answer: 5


Question 2.
How long must an IRB retain records per 21 CFR 56?

Correct Answer: 3 years after completion of research


Question 3.
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


Question 4.
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


Question 5.
How many days does an IRB have to inform the FDA that it is reviewing different types
of FDA products?

Correct Answer: 30 days


Question 6.
How often must an IRB renew it's registration?

Correct Answer: 3 years


Question 7.
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


Question 8.
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


Question 9.
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


Question 10.
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


Question 11.
Sponsors must report SAEs to the FDA within how many days of discovering the event?

Correct Answer: 15 calendar days (21 CFR 312.32)


Question 12.
Investigators must report SAEs to a sponsor within how many days of discovering the
event?

Correct Answer: Immediately (21 CFR 312.64)

,Question 13.
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? -✓✓10 working days (21 CFR 812.15)


Question 14.
Investigators must submit Unanticipated Adverse Device Effects to the FDA within how
many days?

Correct Answer: 10 working days (21 CFR 812.15)


Question 15.
When was the Nuremberg Code issued?

Correct Answer: 1947


Question 16.
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


Question 17.
When was the Declaration of Helsinki released?

Correct Answer: 1964


Question 18.
Who developed the Declaration of Helsinki?

Correct Answer: World Medical Association (WMA)

, Question 19.
What is the Declaration of Helsinki?

Correct Answer: 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


Question 20.
When was the Belmont Report released?

Correct Answer: 1979
• Who created the Belmont Report? -✓✓National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research (at
direction of National Research Act 1974)


Question 21.
What are the 3 principles in the Belmont Report?

Correct Answer: 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)


Question 22.
In what order were historical declarations for human subjects protection released?

Correct Answer: Nuremberg Code > Declaration of Helsinki > Belmont Report


Question 23.
At what reading level should ICFs be written?

Correct Answer: 6th-8th grade


Question 24.
What FDA guideline lists the basic elements of informed consent?

Correct Answer: 21 CFR 50 (50.25)


Question 25.
What are the additional elements of informed consent per FDA guidelines? (7)

Correct Answer: 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