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
...
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
Written for
ACRP
All documents for this subject (436)
Seller
Follow
magdamwikash23
Reviews received
Content preview
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 benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller magdamwikash23. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $11.49. You're not tied to anything after your purchase.
