GOOD CLINICAL PRACTICE (GCP) 55 ACTUAL
QUESTIONS WITH VERIFIED ANSWERS 100%
CORRECT.
1. Which of the following are the three principles includ- Respect for Persons,
ed in the Belmont Report? Beneficence, Justice.
2. Which of the following is an example of how the Princi- Determining that the study
ple of Beneficence can be applied to a study employing has maximized benefits
human subjects? and minimized risks.
3. Which of the following best describes the principle Information, comprehen-
of Respect for Persons ad described in the Belmont sion, voluntariness.
Report
4. Development of most new drugs from discovery to 9 years or more
marketing approval usually takes:
5. Adults with more than a 12-month history of migraines Phase III
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 1200 subjects. Which of the following
best describes the clinical phase of this study?
6. Long-term toxicology of an experimental drug in ani- tigator's
mals most likely refers to which part of drug develop- Brochure?
ment?
7. Pharmacokinetics and pharmacodynamics of a new
formulation of an investigational drug most likely
refers to which clinical phase of a study in humans?
8. For a phase I new drug study in humans, what is the
primary source of the data included in the initial Inves-
, GOOD CLINICAL PRACTICE (GCP) 55 ACTUAL
QUESTIONS WITH VERIFIED ANSWERS 100%
CORRECT.
Preclinical
Phase I
Preclinical data
QUESTIONS WITH VERIFIED ANSWERS 100%
CORRECT.
1. Which of the following are the three principles includ- Respect for Persons,
ed in the Belmont Report? Beneficence, Justice.
2. Which of the following is an example of how the Princi- Determining that the study
ple of Beneficence can be applied to a study employing has maximized benefits
human subjects? and minimized risks.
3. Which of the following best describes the principle Information, comprehen-
of Respect for Persons ad described in the Belmont sion, voluntariness.
Report
4. Development of most new drugs from discovery to 9 years or more
marketing approval usually takes:
5. Adults with more than a 12-month history of migraines Phase III
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 1200 subjects. Which of the following
best describes the clinical phase of this study?
6. Long-term toxicology of an experimental drug in ani- tigator's
mals most likely refers to which part of drug develop- Brochure?
ment?
7. Pharmacokinetics and pharmacodynamics of a new
formulation of an investigational drug most likely
refers to which clinical phase of a study in humans?
8. For a phase I new drug study in humans, what is the
primary source of the data included in the initial Inves-
, GOOD CLINICAL PRACTICE (GCP) 55 ACTUAL
QUESTIONS WITH VERIFIED ANSWERS 100%
CORRECT.
Preclinical
Phase I
Preclinical data
