ACRP Bootcamp Exam (61 Questions) With
100% Correct Verified Answers
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
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
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
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
What event resulted in the Nuremburg Code in 1949?
a. thalidomide tragedy
b. tuskegee syphilis study
c. sulfanilamide Elixir tragedy
d. nazi medical experiments
What is the ICH guideline that is known as the GCP guideline?
a. E2A
b. E6(R2)
, c. E11
d. E9
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
This FDA center that regulates blood, vaccines, gene therapy, and tissues is
a. BIMO
b. CBER
c. CDER
d. CDRH
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
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
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
100% Correct Verified Answers
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
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
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
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
What event resulted in the Nuremburg Code in 1949?
a. thalidomide tragedy
b. tuskegee syphilis study
c. sulfanilamide Elixir tragedy
d. nazi medical experiments
What is the ICH guideline that is known as the GCP guideline?
a. E2A
b. E6(R2)
, c. E11
d. E9
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
This FDA center that regulates blood, vaccines, gene therapy, and tissues is
a. BIMO
b. CBER
c. CDER
d. CDRH
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
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
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
