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CITI Good Clinical Practice Course (US FDA focus)
Exam || Most Recent Verified Exam Actual Complete
Real Exam Questions And Correct Answers (Verified
Answers) Already Graded A+ || Newest Exam!!!
Long-term toxicology of an experimental drug in animals
most likely refers to which part of drug development? -
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? - 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? - Answer-Preclinical data
A primary purpose of the ICH is to: - Answer-Minimize the
need for redundant research.
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The ICH GCP guidelines: - Answer-Set standards for the
design, conduct, monitoring and reporting of clinical
research.
ICH E6 describes standards that apply to: - Answer-
Investigators, sponsors, and IRBs
In the United States, following the ICH E6 guideline is: -
Answer-Voluntary for FDA-regulated drug studies.
The new ICH E6(R2) integrated addendum requires
sponsors to implement systems to manage quality
throughout all stages of the trial process. The system
should use a risk-based approach including which of the
following? - Answer-Identification of study risks to
determine which may safely be omitted from continual
monitoring.
What is the status of ICH in U.S.? - Answer-It is a FDA
guidance.
The data access section of the CTA defines: - Answer-The
various study roles and which study roles have access to
what data
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The budget for a clinical trial: - Answer-Is often
benchmarked using data from third party providers like a
fair market value (FMV) alignment
The CTA's confidentiality clause describes: - Answer-
Handling of proprietary information
In the CTA's subject injury section, it will usually specify
that if a subject in a clinical trial gets hurt, then: - Answer-
Treatment for such injuries will always be available at the
site
The confidential information from the study: - Answer-Must
be protected for the duration indicated in the CTA
Which of the following are the three principles included in
the Belmont Report? - Answer-Respect for Persons,
Beneficence, Justice.
Which of the following is an example of how the Principle
of Beneficence can be applied to a study employing
human subjects? - Answer-Determining that the study has
maximized benefits and minimized risks.
CITI Good Clinical Practice Course (US FDA focus)
Exam || Most Recent Verified Exam Actual Complete
Real Exam Questions And Correct Answers (Verified
Answers) Already Graded A+ || Newest Exam!!!
Long-term toxicology of an experimental drug in animals
most likely refers to which part of drug development? -
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? - 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? - Answer-Preclinical data
A primary purpose of the ICH is to: - Answer-Minimize the
need for redundant research.
,2|Page
The ICH GCP guidelines: - Answer-Set standards for the
design, conduct, monitoring and reporting of clinical
research.
ICH E6 describes standards that apply to: - Answer-
Investigators, sponsors, and IRBs
In the United States, following the ICH E6 guideline is: -
Answer-Voluntary for FDA-regulated drug studies.
The new ICH E6(R2) integrated addendum requires
sponsors to implement systems to manage quality
throughout all stages of the trial process. The system
should use a risk-based approach including which of the
following? - Answer-Identification of study risks to
determine which may safely be omitted from continual
monitoring.
What is the status of ICH in U.S.? - Answer-It is a FDA
guidance.
The data access section of the CTA defines: - Answer-The
various study roles and which study roles have access to
what data
, 3|Page
The budget for a clinical trial: - Answer-Is often
benchmarked using data from third party providers like a
fair market value (FMV) alignment
The CTA's confidentiality clause describes: - Answer-
Handling of proprietary information
In the CTA's subject injury section, it will usually specify
that if a subject in a clinical trial gets hurt, then: - Answer-
Treatment for such injuries will always be available at the
site
The confidential information from the study: - Answer-Must
be protected for the duration indicated in the CTA
Which of the following are the three principles included in
the Belmont Report? - Answer-Respect for Persons,
Beneficence, Justice.
Which of the following is an example of how the Principle
of Beneficence can be applied to a study employing
human subjects? - Answer-Determining that the study has
maximized benefits and minimized risks.
