ACRP
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
ACRP Bootcamp Exam (61 Questions) With 100% Correct Verified Answers
, ACRP
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
ACRP Bootcamp Exam (61 Questions) With 100% Correct Verified Answers
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
ACRP Bootcamp Exam (61 Questions) With 100% Correct Verified Answers
, ACRP
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
ACRP Bootcamp Exam (61 Questions) With 100% Correct Verified Answers
