CITI Training GCP and Refresher Exam Practice Questions and
100% Correct Answers 2026/2027
1. Which of the following defines phase I research as it relates to non-clinical and
other phases of research:: Phase I research is the first phase of research after animal testing and helps define
future phase II and III studies.
2. Approximately how many subjects generally participate in phase I studies?: -
20-80
3. As the amount of adaptive study designs and multiple-arm protocols increas- es,
researchers are now adding small cohorts of a diseased population to phase I
studies to assess the initial safety and effectiveness in the drug's targeted
population. This approach allows researchers to gather preliminary efficacy data
in the diseased population. An example of this would be:: Afirst-in-humanprotocol testing of a
new drug being developed for the treatment of diabetes, including a group of subjects with diabetes.
4. Many phase I studies now include adaptive study designs which allow changes
to the design of the trial as new information is discovered; as is often the case
with phase I studies. According to the author, adaptive trial designs have many
benefits, including:: More eflcient and thorough late phase multicenter research related to dose selection,
subject selection, and safety monitoring.
5. Identify the following type of study design that is generally used in first-in-hu- man
research study:: Single Ascending Dose (SAD)
6. In first-in-human research, researchers review the non-clinical data thorough- ly
to assess if there is sufficient information to support the initiation of human
studies. The highest dose level tested in animal species that did not produce a
significant increase in adverse effects compared to a control group should be
identified. This is identified as the No Observed Adverse Effect Levels (NOAEL)
and is:: Much lower than the expected therapeutic level.
7. Many phase I studies will compensate subjects for their time and participa-
tion in the research. The FDA (1998) includes the following statement in their
Information Sheet on Payment to Research Subjects: "Financial incentives are
often used when health benefits to subjects are remote or non-existent." While
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, payment to subjects is considered a recruitment incentive and not a benefit, it is
common in phase I research to:: Include a compensation stipend.
8. The federal regulations for the informed consent process and documentation are::
The same for all phases of research.
2/9
100% Correct Answers 2026/2027
1. Which of the following defines phase I research as it relates to non-clinical and
other phases of research:: Phase I research is the first phase of research after animal testing and helps define
future phase II and III studies.
2. Approximately how many subjects generally participate in phase I studies?: -
20-80
3. As the amount of adaptive study designs and multiple-arm protocols increas- es,
researchers are now adding small cohorts of a diseased population to phase I
studies to assess the initial safety and effectiveness in the drug's targeted
population. This approach allows researchers to gather preliminary efficacy data
in the diseased population. An example of this would be:: Afirst-in-humanprotocol testing of a
new drug being developed for the treatment of diabetes, including a group of subjects with diabetes.
4. Many phase I studies now include adaptive study designs which allow changes
to the design of the trial as new information is discovered; as is often the case
with phase I studies. According to the author, adaptive trial designs have many
benefits, including:: More eflcient and thorough late phase multicenter research related to dose selection,
subject selection, and safety monitoring.
5. Identify the following type of study design that is generally used in first-in-hu- man
research study:: Single Ascending Dose (SAD)
6. In first-in-human research, researchers review the non-clinical data thorough- ly
to assess if there is sufficient information to support the initiation of human
studies. The highest dose level tested in animal species that did not produce a
significant increase in adverse effects compared to a control group should be
identified. This is identified as the No Observed Adverse Effect Levels (NOAEL)
and is:: Much lower than the expected therapeutic level.
7. Many phase I studies will compensate subjects for their time and participa-
tion in the research. The FDA (1998) includes the following statement in their
Information Sheet on Payment to Research Subjects: "Financial incentives are
often used when health benefits to subjects are remote or non-existent." While
1/9
, payment to subjects is considered a recruitment incentive and not a benefit, it is
common in phase I research to:: Include a compensation stipend.
8. The federal regulations for the informed consent process and documentation are::
The same for all phases of research.
2/9
