Ci Training GCP and Refresher Ques ons and answers
Updated new!! Rated A+ 2025/2026
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 a er animal tes ng and helps define future phase
II and III studies.
Approximately how many subjects generally par cipate in phase I studies?
20-80
As the amount of adap ve study designs and mul ple-arm protocols increases, researchers are
now adding small cohorts of a diseased popula on to phase I studies to assess the ini al safety
and effec veness in the drug's targeted popula on. This approach allows researchers to gather
preliminary efficacy data in the diseased popula on. An example of this would be:
A first-in-human protocol tes ng of a new drug being developed for the treatment of diabetes,
including a group of subjects with diabetes.
Many phase I studies now include adap ve study designs which allow changes to the design of
the trial as new informa on is discovered; as is o en the case with phase I studies. According to
the author, adap ve trial designs have many benefits, including:
More efficient and thorough late phase mul center research related to dose selec on, subject
selec on, and safety monitoring.
Iden fy the following type of study design that is generally used in first-in-human research
study:
Single Ascending Dose (SAD)
In first-in-human research, researchers review the non-clinical data thoroughly to assess if there
is sufficient informa on to support the ini a on 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 iden fied. This is iden fied as the No Observed Adverse Effect Levels
(NOAEL) and is:
Much lower than the expected therapeu c level.
Many phase I studies will compensate subjects for their me and par cipa on in the research.
The FDA (1998) includes the following statement in their Informa on Sheet on Payment to
, Research Subjects: "Financial incen ves are o en used when health benefits to subjects are
remote or non-existent." While payment to subjects is considered a recruitment incen ve and
not a benefit, it is common in phase I research to:
Include a compensa on s pend.
The federal regula ons for the informed consent process and documenta on are:
The same for all phases of research.
The following is an IRB considera on for review of phase I research:
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?
Start with a single ascending dose design to allow for small increments in the dose level.
The ICH E6 guideline should be followed when:
Genera ng clinical trial data that are intended to be submi@ed to regulatory authori es
The two important goals of the ICH E6 standard are:
To assure that the rights, well-being, and confiden ality of trial subjects are protected; to assure
that trial data are credible.
ICH E6 describes standards that apply to:
Inves gators, sponsors, and Ins tu onal Review Boards (IRBs) / Independent Ethics Commi@ees
(IECs) / Research Ethics Boards (REBs).
ICH topics and guidelines fall into four main categories:
Quality, Safety, Efficacy, Mul disciplinary
A primary purpose of the ICH E6 guideline is to:
Minimize the need for redundant research.
According to ICH E6, if a research study is prematurely terminated or suspended for any reason,
the inves gator should no fy the IRB/IEC/REB and applicable regulatory authori es, as well as
which of the following?
Promptly inform the research subjects of the study termina on or suspension and assure
appropriate therapy and follow-up for the research subjects.
Updated new!! Rated A+ 2025/2026
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 a er animal tes ng and helps define future phase
II and III studies.
Approximately how many subjects generally par cipate in phase I studies?
20-80
As the amount of adap ve study designs and mul ple-arm protocols increases, researchers are
now adding small cohorts of a diseased popula on to phase I studies to assess the ini al safety
and effec veness in the drug's targeted popula on. This approach allows researchers to gather
preliminary efficacy data in the diseased popula on. An example of this would be:
A first-in-human protocol tes ng of a new drug being developed for the treatment of diabetes,
including a group of subjects with diabetes.
Many phase I studies now include adap ve study designs which allow changes to the design of
the trial as new informa on is discovered; as is o en the case with phase I studies. According to
the author, adap ve trial designs have many benefits, including:
More efficient and thorough late phase mul center research related to dose selec on, subject
selec on, and safety monitoring.
Iden fy the following type of study design that is generally used in first-in-human research
study:
Single Ascending Dose (SAD)
In first-in-human research, researchers review the non-clinical data thoroughly to assess if there
is sufficient informa on to support the ini a on 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 iden fied. This is iden fied as the No Observed Adverse Effect Levels
(NOAEL) and is:
Much lower than the expected therapeu c level.
Many phase I studies will compensate subjects for their me and par cipa on in the research.
The FDA (1998) includes the following statement in their Informa on Sheet on Payment to
, Research Subjects: "Financial incen ves are o en used when health benefits to subjects are
remote or non-existent." While payment to subjects is considered a recruitment incen ve and
not a benefit, it is common in phase I research to:
Include a compensa on s pend.
The federal regula ons for the informed consent process and documenta on are:
The same for all phases of research.
The following is an IRB considera on for review of phase I research:
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?
Start with a single ascending dose design to allow for small increments in the dose level.
The ICH E6 guideline should be followed when:
Genera ng clinical trial data that are intended to be submi@ed to regulatory authori es
The two important goals of the ICH E6 standard are:
To assure that the rights, well-being, and confiden ality of trial subjects are protected; to assure
that trial data are credible.
ICH E6 describes standards that apply to:
Inves gators, sponsors, and Ins tu onal Review Boards (IRBs) / Independent Ethics Commi@ees
(IECs) / Research Ethics Boards (REBs).
ICH topics and guidelines fall into four main categories:
Quality, Safety, Efficacy, Mul disciplinary
A primary purpose of the ICH E6 guideline is to:
Minimize the need for redundant research.
According to ICH E6, if a research study is prematurely terminated or suspended for any reason,
the inves gator should no fy the IRB/IEC/REB and applicable regulatory authori es, as well as
which of the following?
Promptly inform the research subjects of the study termina on or suspension and assure
appropriate therapy and follow-up for the research subjects.
