PCIP STUDY PRACTICE EXAM 2026
QUESTIONS WITH SOLUTIONS GRADED A+
◉ Approximately how many subjects generally participate in phase I
studies? Answer: 20-80
◉ As the amount of adaptive study designs and multiple-arm
protocols increases, 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: Answer: A first-in-human
protocol testing of a new drug being developed for the treatment of
diabetes, including a group of subjects with diabetes.
◉ 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: Answer:
More efficient and thorough late phase multicenter research related
to dose selection, subject selection, and safety monitoring.
◉ Identify the following type of study design that is generally used
in first-in-human research study: Answer: Single Ascending Dose
(SAD)
, ◉ In first-in-human research, researchers review the non-clinical
data thoroughly 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:
Answer: Much lower than the expected therapeutic level.
◉ Many phase I studies will compensate subjects for their time and
participation 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 payment to subjects is
considered a recruitment incentive and not a benefit, it is common
in phase I research to: Answer: Include a compensation stipend.
◉ The federal regulations for the informed consent process and
documentation are: Answer: The same for all phases of research.
◉ The following is an IRB consideration for review of phase I
research: Answer: Type of subjects enrolled
◉ Which of the following is a safeguard that can be used to protect
healthy research subjects involved in first-in-human research?
QUESTIONS WITH SOLUTIONS GRADED A+
◉ Approximately how many subjects generally participate in phase I
studies? Answer: 20-80
◉ As the amount of adaptive study designs and multiple-arm
protocols increases, 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: Answer: A first-in-human
protocol testing of a new drug being developed for the treatment of
diabetes, including a group of subjects with diabetes.
◉ 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: Answer:
More efficient and thorough late phase multicenter research related
to dose selection, subject selection, and safety monitoring.
◉ Identify the following type of study design that is generally used
in first-in-human research study: Answer: Single Ascending Dose
(SAD)
, ◉ In first-in-human research, researchers review the non-clinical
data thoroughly 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:
Answer: Much lower than the expected therapeutic level.
◉ Many phase I studies will compensate subjects for their time and
participation 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 payment to subjects is
considered a recruitment incentive and not a benefit, it is common
in phase I research to: Answer: Include a compensation stipend.
◉ The federal regulations for the informed consent process and
documentation are: Answer: The same for all phases of research.
◉ The following is an IRB consideration for review of phase I
research: Answer: Type of subjects enrolled
◉ Which of the following is a safeguard that can be used to protect
healthy research subjects involved in first-in-human research?
