CCRP EXAM | 2025/2026 UPDATE | 273 QUESTIONS
AND ANSWERS | WITH COMPLETE SOLUTION!!
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
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
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)
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
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? Answer - 1964
Who developed the Declaration of Helsinki? Answer - World Medical
Association (WMA)
What is the Declaration of Helsinki? 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
When was the Belmont Report released? Answer - 1979
Who created the Belmont Report? Answer - National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research (at
direction of National Research Act 1974)
AND ANSWERS | WITH COMPLETE SOLUTION!!
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
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
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)
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
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? Answer - 1964
Who developed the Declaration of Helsinki? Answer - World Medical
Association (WMA)
What is the Declaration of Helsinki? 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
When was the Belmont Report released? Answer - 1979
Who created the Belmont Report? Answer - National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research (at
direction of National Research Act 1974)
