CITI TRAINING GCP AND REFRESHER
T
QUESTIONS WITH CORRECT ANSWERS
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.
Approximately how many subjects generally participate in phase I studies? - 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: - 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: - 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: - 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: - 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: - Include a compensation stipend.
The federal regulations for the informed consent process and documentation are: - The same for all
phases of research.
The following is an IRB consideration 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: - Generating clinical trial data that are intended to be
submitted to regulatory authorities
The two important goals of the ICH E6 standard are: - 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: - Investigators, sponsors, and Institutional Review Boards (IRBs)
/ Independent Ethics Committees (IECs) / Research Ethics Boards (REBs).
ICH topics and guidelines fall into four main categories: - Quality, Safety, Efficacy, Multidisciplinary
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
investigator should notify the IRB/IEC/REB and applicable regulatory authorities, as well as which of the
following? - Promptly inform the research subjects of the study termination or suspension and assure
appropriate therapy and follow-up for the research subjects.
Delegation of study-related tasks by the qualified/principal investigator to other study team members
(for example, completion of the Case Report Form [CRF]) is permitted, provided that: - The individual has
been trained/experienced in the task and has signed the task delegation log.
According to ICH E6 Section 4.11.1, the investigator should notify the sponsor of serious adverse events
(SAE): - As soon as possible after the investigator is aware of the SAE
According to ICH E6 the investigator should fulfill the following criteria:
Meet all the qualifications specified by the applicable regulatory requirements.
Provide evidence of qualification through a Curriculum Vitae and other documentation requested as
applicable by the sponsor, the IRB/IEC/REB, regulatory authorities and institution.
What is the additional requirement stated by ICH E6? - Be qualified by education, training and
experience
Which of the following statements appears in ICH E6 Section 4.2 entitled "Adequate Resources?" - The
investigator should ensure that all persons assisting with the trial are adequately informed about the
protocol, the investigational product(s), and their trial-related duties and functions.
A 46-year-old man is currently enrolled in a Phase 3 study of a drug for severe diabetic neuropathy.
While the study is ongoing, a new drug becomes commercially available that may have equal or greater
benefit to the subject. The investigator should do which of the following? - Discuss the pros and cons of
both the investigational drug and the commercially available drug and then allow the subject to decide
whether to withdraw from the research to take the new drug
When should informed consent be obtained? - Prior to initiating any requirements of the study protocol.
T
QUESTIONS WITH CORRECT ANSWERS
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.
Approximately how many subjects generally participate in phase I studies? - 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: - 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: - 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: - 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: - 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: - Include a compensation stipend.
The federal regulations for the informed consent process and documentation are: - The same for all
phases of research.
The following is an IRB consideration 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: - Generating clinical trial data that are intended to be
submitted to regulatory authorities
The two important goals of the ICH E6 standard are: - 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: - Investigators, sponsors, and Institutional Review Boards (IRBs)
/ Independent Ethics Committees (IECs) / Research Ethics Boards (REBs).
ICH topics and guidelines fall into four main categories: - Quality, Safety, Efficacy, Multidisciplinary
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
investigator should notify the IRB/IEC/REB and applicable regulatory authorities, as well as which of the
following? - Promptly inform the research subjects of the study termination or suspension and assure
appropriate therapy and follow-up for the research subjects.
Delegation of study-related tasks by the qualified/principal investigator to other study team members
(for example, completion of the Case Report Form [CRF]) is permitted, provided that: - The individual has
been trained/experienced in the task and has signed the task delegation log.
According to ICH E6 Section 4.11.1, the investigator should notify the sponsor of serious adverse events
(SAE): - As soon as possible after the investigator is aware of the SAE
According to ICH E6 the investigator should fulfill the following criteria:
Meet all the qualifications specified by the applicable regulatory requirements.
Provide evidence of qualification through a Curriculum Vitae and other documentation requested as
applicable by the sponsor, the IRB/IEC/REB, regulatory authorities and institution.
What is the additional requirement stated by ICH E6? - Be qualified by education, training and
experience
Which of the following statements appears in ICH E6 Section 4.2 entitled "Adequate Resources?" - The
investigator should ensure that all persons assisting with the trial are adequately informed about the
protocol, the investigational product(s), and their trial-related duties and functions.
A 46-year-old man is currently enrolled in a Phase 3 study of a drug for severe diabetic neuropathy.
While the study is ongoing, a new drug becomes commercially available that may have equal or greater
benefit to the subject. The investigator should do which of the following? - Discuss the pros and cons of
both the investigational drug and the commercially available drug and then allow the subject to decide
whether to withdraw from the research to take the new drug
When should informed consent be obtained? - Prior to initiating any requirements of the study protocol.
