CCRP EXAM 273 PRACTICE QUESTIONS AND
DETAILED SOLUTIONS
◉ 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)
◉ What are the 3 principles in the Belmont Report?
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)
◉ In what order were historical declarations for human subjects
protection released?
Answer: Nuremberg Code > Declaration of Helsinki > Belmont
Report
◉ At what reading level should ICFs be written?
Answer: 6th-8th grade
◉ What FDA guideline lists the basic elements of informed consent?
Answer: 21 CFR 50 (50.25)
◉ What are the additional elements of informed consent per FDA
guidelines? (7)
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
5) Statement that new findings will be provided to subject
6) # of subjects in study
7) clinicaltrials.gov statement (as applicable)
DETAILED SOLUTIONS
◉ 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)
◉ What are the 3 principles in the Belmont Report?
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)
◉ In what order were historical declarations for human subjects
protection released?
Answer: Nuremberg Code > Declaration of Helsinki > Belmont
Report
◉ At what reading level should ICFs be written?
Answer: 6th-8th grade
◉ What FDA guideline lists the basic elements of informed consent?
Answer: 21 CFR 50 (50.25)
◉ What are the additional elements of informed consent per FDA
guidelines? (7)
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
5) Statement that new findings will be provided to subject
6) # of subjects in study
7) clinicaltrials.gov statement (as applicable)
