CCRP EXAM TEST BANK SOLVED QUESTIONS 100 PERCENT CORRECT ANSWERS
CCRP Exam Questions and Answers Verified
Solutions Latest Update 2026/2027
Question:
How many members must sit on an IRB?
Answer:
5
Question:
How long must an IRB retain records per 21 CFR 56?
Answer:
3 years after completion of research
Question:
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
Question:
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
,Question:
How many days does an IRB have to inform the FDA that it is reviewing different types of FDA
products?
Answer:
30 days
Question:
How often must an IRB renew it's registration?
Answer:
3 years
Question:
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
Question:
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
Question:
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
Question:
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
Question:
Sponsors must report SAEs to the FDA within how many days of discovering the event?
Answer:
15 calendar days (21 CFR 312.32)
Question:
Investigators must report SAEs to a sponsor within how many days of discovering the event?
Answer:
Immediately (21 CFR 312.64)
Question:
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
, Question:
Sponsors must submit Unanticipated Adverse Device Effects to the FDA within how many days?
Answer:
10 working days (21 CFR 812.15)
Question:
Investigators must submit Unanticipated Adverse Device Effects to the FDA within how many
days?
Answer:
10 working days (21 CFR 812.15)
Question:
When was the Nuremberg Code issued?
Answer:
1947
Question:
What are the 10 points made in the Nuremberg Code?
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:
When was the Declaration of Helsinki released?
Answer:
CCRP Exam Questions and Answers Verified
Solutions Latest Update 2026/2027
Question:
How many members must sit on an IRB?
Answer:
5
Question:
How long must an IRB retain records per 21 CFR 56?
Answer:
3 years after completion of research
Question:
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
Question:
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
,Question:
How many days does an IRB have to inform the FDA that it is reviewing different types of FDA
products?
Answer:
30 days
Question:
How often must an IRB renew it's registration?
Answer:
3 years
Question:
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
Question:
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
Question:
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
Question:
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
Question:
Sponsors must report SAEs to the FDA within how many days of discovering the event?
Answer:
15 calendar days (21 CFR 312.32)
Question:
Investigators must report SAEs to a sponsor within how many days of discovering the event?
Answer:
Immediately (21 CFR 312.64)
Question:
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
, Question:
Sponsors must submit Unanticipated Adverse Device Effects to the FDA within how many days?
Answer:
10 working days (21 CFR 812.15)
Question:
Investigators must submit Unanticipated Adverse Device Effects to the FDA within how many
days?
Answer:
10 working days (21 CFR 812.15)
Question:
When was the Nuremberg Code issued?
Answer:
1947
Question:
What are the 10 points made in the Nuremberg Code?
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:
When was the Declaration of Helsinki released?
Answer:
