CCRP Exam Questions and Answers |
100% Correct Answers | Graded A+
• How many members must sit on an IRB? -✓✓5
• How long must an IRB retain records per 21 CFR 56? -✓✓3 years after
completion of research
• What are the criteria for IRB approval of research? (7) -✓✓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? -✓✓90 days
• How many days does an IRB have to inform the FDA that it is
reviewing different types of FDA products? -✓✓30 days
• How often must an IRB renew it's registration? -✓✓3 years
• What are the 8 basic elements of informed consent per FDA
guidelines? -✓✓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) -✓✓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) -✓✓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) -✓✓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? -✓✓15 calendar days (21 CFR 312.32)
• Investigators must report SAEs to a sponsor within how many days of
discovering the event? -✓✓Immediately (21 CFR 312.64)
• Sponsors must report what kind of serious events to the FDA within 15
calendar days? (4) -✓✓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)
• Investigators must submit Unanticipated Adverse Device Effects to the
FDA within how many days? -✓✓10 working days (21 CFR 812.15)
• When was the Nuremberg Code issued? -✓✓1947
• What are the 10 points made in the Nuremberg Code? -✓✓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? -✓✓1964
• Who developed the Declaration of Helsinki? -✓✓World Medical
Association (WMA)
• What is the Declaration of Helsinki? -✓✓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? -✓✓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)
• What are the 3 principles in the Belmont Report? -✓✓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? -✓✓Nuremberg Code > Declaration of Helsinki >
Belmont Report
• At what reading level should ICFs be written? -✓✓6th-8th grade
• What FDA guideline lists the basic elements of informed consent? -
✓✓21 CFR 50 (50.25)
• What are the additional elements of informed consent per FDA
guidelines? (7) -✓✓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? -✓✓IRB - sponsor can provide
sample form
100% Correct Answers | Graded A+
• How many members must sit on an IRB? -✓✓5
• How long must an IRB retain records per 21 CFR 56? -✓✓3 years after
completion of research
• What are the criteria for IRB approval of research? (7) -✓✓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? -✓✓90 days
• How many days does an IRB have to inform the FDA that it is
reviewing different types of FDA products? -✓✓30 days
• How often must an IRB renew it's registration? -✓✓3 years
• What are the 8 basic elements of informed consent per FDA
guidelines? -✓✓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) -✓✓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) -✓✓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) -✓✓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? -✓✓15 calendar days (21 CFR 312.32)
• Investigators must report SAEs to a sponsor within how many days of
discovering the event? -✓✓Immediately (21 CFR 312.64)
• Sponsors must report what kind of serious events to the FDA within 15
calendar days? (4) -✓✓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)
• Investigators must submit Unanticipated Adverse Device Effects to the
FDA within how many days? -✓✓10 working days (21 CFR 812.15)
• When was the Nuremberg Code issued? -✓✓1947
• What are the 10 points made in the Nuremberg Code? -✓✓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? -✓✓1964
• Who developed the Declaration of Helsinki? -✓✓World Medical
Association (WMA)
• What is the Declaration of Helsinki? -✓✓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? -✓✓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)
• What are the 3 principles in the Belmont Report? -✓✓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? -✓✓Nuremberg Code > Declaration of Helsinki >
Belmont Report
• At what reading level should ICFs be written? -✓✓6th-8th grade
• What FDA guideline lists the basic elements of informed consent? -
✓✓21 CFR 50 (50.25)
• What are the additional elements of informed consent per FDA
guidelines? (7) -✓✓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? -✓✓IRB - sponsor can provide
sample form
