CITI Training - Good Clinical Practice Exam | All
Questions and Correct Answers | Already
Graded A+ | Verified Answers | Latest Version
2025 | Just Released
An investigator is confronted with a life-threatening situation that necessitates
using a test article in a human subject who is unable to provide informed consent
and there is no time to obtain consent for the individual's legal representative.
Under the FDA regulations, which of the following describes the best course of
action for the investigator: ---------CORRECT ANSWER-----------------The investigator
and another physician not part of the study team agree that the situation
necessitates the use of the test article and the IRB will be notified later.
A 46-year-old man is currently enrolled in a Phase III 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? ---------CORRECT ANSWER-------------
----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.
Development of most new drugs, from discovery to marketing approval, usually
takes: ---------CORRECT ANSWER-----------------9 years or more
, Adults with more than a twelve (12)-month history of migraines were assigned
randomly in a double-blinded study to receive treatment with experimental drug
X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction
in severity of the migraine attacks. Enrollment was twelve-hundred (1200)
subjects. Which of the following best describes the clinical phase of this study? ----
-----CORRECT ANSWER-----------------Phase III
Long-term toxicology of an experimental drug in animals most likely refers to
which part of drug development? ---------CORRECT ANSWER-----------------
Preclinical
Pharmacokinetics and pharmacodynamics of a new formulation of an
investigational drug most likely refers to which clinical phase of a study in
humans? ---------CORRECT ANSWER-----------------Phase I
For a Phase I new drug study in humans, what is the primary source of the data
included in the initial Investigator's Brochure? ---------CORRECT ANSWER-------------
----Preclinical data
A primary purpose of the ICH is to: ---------CORRECT ANSWER-----------------
Minimize the need for redundant research.
Questions and Correct Answers | Already
Graded A+ | Verified Answers | Latest Version
2025 | Just Released
An investigator is confronted with a life-threatening situation that necessitates
using a test article in a human subject who is unable to provide informed consent
and there is no time to obtain consent for the individual's legal representative.
Under the FDA regulations, which of the following describes the best course of
action for the investigator: ---------CORRECT ANSWER-----------------The investigator
and another physician not part of the study team agree that the situation
necessitates the use of the test article and the IRB will be notified later.
A 46-year-old man is currently enrolled in a Phase III 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? ---------CORRECT ANSWER-------------
----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.
Development of most new drugs, from discovery to marketing approval, usually
takes: ---------CORRECT ANSWER-----------------9 years or more
, Adults with more than a twelve (12)-month history of migraines were assigned
randomly in a double-blinded study to receive treatment with experimental drug
X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction
in severity of the migraine attacks. Enrollment was twelve-hundred (1200)
subjects. Which of the following best describes the clinical phase of this study? ----
-----CORRECT ANSWER-----------------Phase III
Long-term toxicology of an experimental drug in animals most likely refers to
which part of drug development? ---------CORRECT ANSWER-----------------
Preclinical
Pharmacokinetics and pharmacodynamics of a new formulation of an
investigational drug most likely refers to which clinical phase of a study in
humans? ---------CORRECT ANSWER-----------------Phase I
For a Phase I new drug study in humans, what is the primary source of the data
included in the initial Investigator's Brochure? ---------CORRECT ANSWER-------------
----Preclinical data
A primary purpose of the ICH is to: ---------CORRECT ANSWER-----------------
Minimize the need for redundant research.
