Exam (elaborations)
ACRP Bootcamp Exam (61 Questions) With 100% Correct & Verified Answers
- Course
- Institution
ACRP Bootcamp Exam (61 Questions) With 100% Correct & Verified Answers
[Show more]
Content preview
ACRP Bootcamp Exam (61 Questions) With100% 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
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 Boffin. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $13.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
81113 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now