CCRP Exam
CCRP (Certified Clinical Research
Professional) Exam Questions
Containing 273 terms and Definitions
2024-2025.
How many days does a sponsor have to report an emergency use of an IP to the
FDA? - Answer: 5 working days
How many members must sit on an IRB? - Answer: 5
, CCRP Exam
How long must an IRB retain records per 21 CFR 56? - Answer: 3 years after
completion of research
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
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
How many days does an IRB have to inform the FDA that it is reviewing different
types of FDA products? - Answer: 30 days
How often must an IRB renew it's registration? - Answer: 3 years
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
, CCRP Exam
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) - Answer:
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) - 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
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
Sponsors must report SAEs to the FDA within how many days of discovering the
event? - Answer: 15 calendar days (21 CFR 312.32)
, CCRP Exam
Investigators must report SAEs to a sponsor within how many days of discovering
the event? - Answer: Immediately (21 CFR 312.64)
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
Sponsors must submit Unanticipated Adverse Device Effects to the FDA within
how many days? - Answer: 10 working days (21 CFR 812.15)
Investigators must submit Unanticipated Adverse Device Effects to the FDA within
how many days? - Answer: 10 working days (21 CFR 812.15)
When was the Nuremberg Code issued? - Answer: 1947
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
CCRP (Certified Clinical Research
Professional) Exam Questions
Containing 273 terms and Definitions
2024-2025.
How many days does a sponsor have to report an emergency use of an IP to the
FDA? - Answer: 5 working days
How many members must sit on an IRB? - Answer: 5
, CCRP Exam
How long must an IRB retain records per 21 CFR 56? - Answer: 3 years after
completion of research
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
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
How many days does an IRB have to inform the FDA that it is reviewing different
types of FDA products? - Answer: 30 days
How often must an IRB renew it's registration? - Answer: 3 years
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
, CCRP Exam
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) - Answer:
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) - 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
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
Sponsors must report SAEs to the FDA within how many days of discovering the
event? - Answer: 15 calendar days (21 CFR 312.32)
, CCRP Exam
Investigators must report SAEs to a sponsor within how many days of discovering
the event? - Answer: Immediately (21 CFR 312.64)
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
Sponsors must submit Unanticipated Adverse Device Effects to the FDA within
how many days? - Answer: 10 working days (21 CFR 812.15)
Investigators must submit Unanticipated Adverse Device Effects to the FDA within
how many days? - Answer: 10 working days (21 CFR 812.15)
When was the Nuremberg Code issued? - Answer: 1947
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
