ACRP Bootcamp Exam 2023 with complete solution
The clinical trial phase that focuses on safety and human pharmacology in
healthy volunteers is:
a. phase 1
b. phase 2
c. phase 3
d. phase 4
a
Which of the following is not a type of patient-oriented research?
a. IND/IDE clinical trials
b. investigator initiated trial (IIT)
c. Post market device registries
d. outcome and health services research
d
Who is ultimately responsible for all aspects of the research conducted at a site?
a. IRB
b. sponsor
c. principal investigator
d. clinical research coordinator
c
What is the definition of good clinical practice (GCP)?
a. training provided by sponsors to site staff
b. regulations provided by the FDA
c. standards developed by european union
d. an international quality standard that is provided by ICH
d
What event resulted in the Nuremburg Code in 1949?
a. thalidomide tragedy
b. tuskegee syphilis study
c. sulfanilamide Elixir tragedy
d. nazi medical experiments
d
What is the ICH guideline that is known as the GCP guideline?
a. E2A
b. E6(R2)
c. E11
d. E9
b
, Which o the following is not a basic ethical principle according to the Belmont
Report?
a. vulnerability
b. beneficence
c. respect for persons
d. justice
a
This FDA center that regulates blood, vaccines, gene therapy, and tissues is
a. BIMO
b. CBER
c. CDER
d. CDRH
b
What is the international conference on harmonization (ICH) guidelines?
a. written policies for researchers on how to maintain data on unmarketed
investigational products
b. a guideline provided by the office for human research protection for subjects
enrolling in phase 1 studies
c. a unified standard to facilitate the mutual acceptance of clinical data by the
regulatory authorities in the european union, japan and the united states
d. an international standard for manufacturing, transporting, and storing
medicinal products
c
To be a qualifying clinical trial, which three requirements must be met?
a. the trial has therapeutic intent, has an investigational new drug number, and
enrolls patients with diagnosed disease
b. the trial has therapeutic intent, enrolls patients with diagnosed disease and
evaluates an item/service that falls within a medicare benefit category
c. the trial has therapeutic intent, has an investigational new drug number, and
does not evaluate an item/service that falls within a medicare benefit category
d. the trial has an investigational new drug number, does not enroll patients with
diagnosed disease and evlauates an item/service that falls within a medicare
benefit category
b
A process by which a subject voluntarily confirms his or her willingness to
participate in a particular trial, after having been informed of all aspects of the
trial that are relevant to the subject's decision to participate is known as an:
a. assent
b. informed consent
c. subject agreement
d. dissent
The clinical trial phase that focuses on safety and human pharmacology in
healthy volunteers is:
a. phase 1
b. phase 2
c. phase 3
d. phase 4
a
Which of the following is not a type of patient-oriented research?
a. IND/IDE clinical trials
b. investigator initiated trial (IIT)
c. Post market device registries
d. outcome and health services research
d
Who is ultimately responsible for all aspects of the research conducted at a site?
a. IRB
b. sponsor
c. principal investigator
d. clinical research coordinator
c
What is the definition of good clinical practice (GCP)?
a. training provided by sponsors to site staff
b. regulations provided by the FDA
c. standards developed by european union
d. an international quality standard that is provided by ICH
d
What event resulted in the Nuremburg Code in 1949?
a. thalidomide tragedy
b. tuskegee syphilis study
c. sulfanilamide Elixir tragedy
d. nazi medical experiments
d
What is the ICH guideline that is known as the GCP guideline?
a. E2A
b. E6(R2)
c. E11
d. E9
b
, Which o the following is not a basic ethical principle according to the Belmont
Report?
a. vulnerability
b. beneficence
c. respect for persons
d. justice
a
This FDA center that regulates blood, vaccines, gene therapy, and tissues is
a. BIMO
b. CBER
c. CDER
d. CDRH
b
What is the international conference on harmonization (ICH) guidelines?
a. written policies for researchers on how to maintain data on unmarketed
investigational products
b. a guideline provided by the office for human research protection for subjects
enrolling in phase 1 studies
c. a unified standard to facilitate the mutual acceptance of clinical data by the
regulatory authorities in the european union, japan and the united states
d. an international standard for manufacturing, transporting, and storing
medicinal products
c
To be a qualifying clinical trial, which three requirements must be met?
a. the trial has therapeutic intent, has an investigational new drug number, and
enrolls patients with diagnosed disease
b. the trial has therapeutic intent, enrolls patients with diagnosed disease and
evaluates an item/service that falls within a medicare benefit category
c. the trial has therapeutic intent, has an investigational new drug number, and
does not evaluate an item/service that falls within a medicare benefit category
d. the trial has an investigational new drug number, does not enroll patients with
diagnosed disease and evlauates an item/service that falls within a medicare
benefit category
b
A process by which a subject voluntarily confirms his or her willingness to
participate in a particular trial, after having been informed of all aspects of the
trial that are relevant to the subject's decision to participate is known as an:
a. assent
b. informed consent
c. subject agreement
d. dissent
