Citi Training GCP and Refresher Questions With All
Correct Answers
Which of the following defines phase I research as it relates to non-clinical and
other phases of research: correct 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?
correct 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:
correct 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: correct 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: correct 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: correct 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: correct answer -Include a
compensation stipend.
The federal regulations for the informed consent process and documentation
are: correct answer -The same for all phases of research.
The following is an IRB consideration for review of phase I research: correct
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? correct answer -
Start with a single ascending dose design to allow for small increments in the
dose level.
The ICH E6 guideline should be followed when: correct answer -
Generating clinical trial data that are intended to be submitted to regulatory
authorities
The two important goals of the ICH E6 standard are: correct answer -To
assure that the rights, well-being, and confidentiality of trial subjects are
protected; to assure that trial data are credible.
ICH E6 describes standards that apply to: correct answer -Investigators,
sponsors, and Institutional Review Boards (IRBs) / Independent Ethics
Committees (IECs) / Research Ethics Boards (REBs).
ICH topics and guidelines fall into four main categories: correct answer -
Quality, Safety, Efficacy, Multidisciplinary
A primary purpose of the ICH E6 guideline is to: correct answer -Minimize
the need for redundant research.
According to ICH E6, if a research study is prematurely terminated or
suspended for any reason, the investigator should notify the IRB/IEC/REB and
Correct Answers
Which of the following defines phase I research as it relates to non-clinical and
other phases of research: correct 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?
correct 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:
correct 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: correct 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: correct 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: correct 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: correct answer -Include a
compensation stipend.
The federal regulations for the informed consent process and documentation
are: correct answer -The same for all phases of research.
The following is an IRB consideration for review of phase I research: correct
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? correct answer -
Start with a single ascending dose design to allow for small increments in the
dose level.
The ICH E6 guideline should be followed when: correct answer -
Generating clinical trial data that are intended to be submitted to regulatory
authorities
The two important goals of the ICH E6 standard are: correct answer -To
assure that the rights, well-being, and confidentiality of trial subjects are
protected; to assure that trial data are credible.
ICH E6 describes standards that apply to: correct answer -Investigators,
sponsors, and Institutional Review Boards (IRBs) / Independent Ethics
Committees (IECs) / Research Ethics Boards (REBs).
ICH topics and guidelines fall into four main categories: correct answer -
Quality, Safety, Efficacy, Multidisciplinary
A primary purpose of the ICH E6 guideline is to: correct answer -Minimize
the need for redundant research.
According to ICH E6, if a research study is prematurely terminated or
suspended for any reason, the investigator should notify the IRB/IEC/REB and
