Citi Training GCP and Refresher
Exam Questions and Answers
100% PASS
Which of the following defines phase I research as it relates to non-clinical and other phases
of research:—ANSWER-Phase I research is the first phase of research after animal testing
and helps define future phase II and III studies.
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?—ANSWER-Start with a single ascending dose design to
allow for small increments in the dose level.
© 2026 Copyright. All Rights Reserved. This document is
protected by copyright law, Copyrighted By Brittie Donald
Exam Questions and Answers
100% PASS
Which of the following defines phase I research as it relates to non-clinical and other phases
of research:—ANSWER-Phase I research is the first phase of research after animal testing
and helps define future phase II and III studies.
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?—ANSWER-Start with a single ascending dose design to
allow for small increments in the dose level.
© 2026 Copyright. All Rights Reserved. This document is
protected by copyright law, Copyrighted By Brittie Donald
