GOOD CLINICAL PRACTICE ACTUAL PAPER
2026 QUESTIONS SOLUTIONS GRADED A+
◉ ________________is the degree to which, or the rate at which, a
medication or other substance is absorbed or becomes available at
the targeted place in the body. Answer: Bioavailability
◉ ___________________ means that subjects are split into at least two
groups: those receiving the experimental agent and those receiving a
standard treatment for the condition (an active control), no
treatment, or a placebo. If subjects are assigned randomly into these
groups, the study is a randomized controlled trial. Answer:
Controlled
◉ ______________ is a standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting of clinical
trials. Answer: Good Clinical Practice (GCP)
◉ __________________ describes the effects of the agent while in the
body. Answer: Pharmacodynamics
◉ ________________is the use of genetic information to predict whether
a drug will help make a patient well or ill. Answer:
Pharmacogenomics
,◉ ___________________________describes how the agent moves through
and is excreted from the body. Answer: Pharmacokinetics
◉ The first step in the drug-development process allows
investigators to evaluate the drug using tissue cultures and animal
models. This research is referred to as ______________. Answer:
preclinical studies
◉ _________________ is a compilation of the pre-clinical and clinical data
on the investigational product(s) that are relevant to the study of the
product(s) in human subjects. Answer: The Investigator's Brochure
(IB)
◉ ICH E6 also defines what a "____________________" of the original
record is. In order for a record to be (this), the paper or electronic
copy of the original record must have been verified (for example, by
a dated signature) or generated through a validated process to
produce an exact copy of the original. Answer: Certified Copy
◉ The first Investigator's Brochure IB for a proposed clinical trial of
a new drug is based primarily on which of the following?
a) preclinical trials
b) Phase II studies. Answer: preclinical trials
,◉ Development of most new drugs, from discovery to marketing
approval, usually takes:
A) 5 years
B) Less than 5 months
C) 1-3 years
D) 9 years or more Answer: D
◉ 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?
A) Phase II
B) Phase III
C) Pre-clinical
D) Phase I Answer: B
◉ Long-term toxicology of an experimental drug in animals most
likely refers to which part of drug development?
A) Phase II
B)Pre-clinical
C) Phase I
, D) Phase III Answer: B
◉ Pharmacokinetics and pharmacodynamics of a new formulation
of an investigational drug most likely refers to which clinical phase
of a study in humans?
A) Phase II
B) Pre-clinical
C) Phase I
D) Phase III Answer: C
◉ For a Phase I new drug study in humans, what is the primary
source of the data included in the initial Investigator's Brochure?
A) Clinical Trails
B) FDA files
C) Post-approval Surveillance Studies
D) Pre-clinical data. Answer: D
◉ _______________________is generally an unplanned excursion from the
requirements of the protocol that is not implemented or intended as
a systematic change. Answer: Protocol Deviation (or Violation)
◉ _____________________ is an individual, or judicial or other body,
authorized under applicable law to consent on behalf of a
prospective subject to the subject's participation in the procedure(s)
2026 QUESTIONS SOLUTIONS GRADED A+
◉ ________________is the degree to which, or the rate at which, a
medication or other substance is absorbed or becomes available at
the targeted place in the body. Answer: Bioavailability
◉ ___________________ means that subjects are split into at least two
groups: those receiving the experimental agent and those receiving a
standard treatment for the condition (an active control), no
treatment, or a placebo. If subjects are assigned randomly into these
groups, the study is a randomized controlled trial. Answer:
Controlled
◉ ______________ is a standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting of clinical
trials. Answer: Good Clinical Practice (GCP)
◉ __________________ describes the effects of the agent while in the
body. Answer: Pharmacodynamics
◉ ________________is the use of genetic information to predict whether
a drug will help make a patient well or ill. Answer:
Pharmacogenomics
,◉ ___________________________describes how the agent moves through
and is excreted from the body. Answer: Pharmacokinetics
◉ The first step in the drug-development process allows
investigators to evaluate the drug using tissue cultures and animal
models. This research is referred to as ______________. Answer:
preclinical studies
◉ _________________ is a compilation of the pre-clinical and clinical data
on the investigational product(s) that are relevant to the study of the
product(s) in human subjects. Answer: The Investigator's Brochure
(IB)
◉ ICH E6 also defines what a "____________________" of the original
record is. In order for a record to be (this), the paper or electronic
copy of the original record must have been verified (for example, by
a dated signature) or generated through a validated process to
produce an exact copy of the original. Answer: Certified Copy
◉ The first Investigator's Brochure IB for a proposed clinical trial of
a new drug is based primarily on which of the following?
a) preclinical trials
b) Phase II studies. Answer: preclinical trials
,◉ Development of most new drugs, from discovery to marketing
approval, usually takes:
A) 5 years
B) Less than 5 months
C) 1-3 years
D) 9 years or more Answer: D
◉ 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?
A) Phase II
B) Phase III
C) Pre-clinical
D) Phase I Answer: B
◉ Long-term toxicology of an experimental drug in animals most
likely refers to which part of drug development?
A) Phase II
B)Pre-clinical
C) Phase I
, D) Phase III Answer: B
◉ Pharmacokinetics and pharmacodynamics of a new formulation
of an investigational drug most likely refers to which clinical phase
of a study in humans?
A) Phase II
B) Pre-clinical
C) Phase I
D) Phase III Answer: C
◉ For a Phase I new drug study in humans, what is the primary
source of the data included in the initial Investigator's Brochure?
A) Clinical Trails
B) FDA files
C) Post-approval Surveillance Studies
D) Pre-clinical data. Answer: D
◉ _______________________is generally an unplanned excursion from the
requirements of the protocol that is not implemented or intended as
a systematic change. Answer: Protocol Deviation (or Violation)
◉ _____________________ is an individual, or judicial or other body,
authorized under applicable law to consent on behalf of a
prospective subject to the subject's participation in the procedure(s)
