ACRP-CP EXAM NEWEST ACTUAL
EXAM STUDY GUIDE QUESTIONS AND
DETAILED CORRECT ANSWERS | A+
GRADE 2024-2025
To be a qualifying clinical trial, which three requirements
must be met? Correct Answer Therapeutic Intent
Enrolls patients with diagnosed disease
Evaluates an item/service that falls within a Medicare
Benefit Category
Define informed consent Correct Answer 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
subjects decision to participate.
Primary purpose of IRB Correct Answer To ensure the
protection of the rights and welfare of the human subjects
When can IRB waive informed consent? Correct Answer
IRB has the ability to waive the informed consent
requirement if the research is no more than minimal risk
and involves no procedures for which consent is required
outside of the research context and in emergency
research
An investigational New Drug (IND) Application becomes
effective ___ days after receipt by the FDA (barring a hold,
,request for additional information, or rejection of an
application); is valid one year; and must be updated within
___ days of taking effect. Correct Answer 30, 60
What is the purpose of the IRB/IEC? Correct Answer An
IRB/IEC should safeguard the rights, safety, and well-
being of all trial subjects. Special attention should be paid
to trials that may include vulnerable subjects.
How frequently should the IRB/IEC conduct a CR of each
ongoing trial? Correct Answer The IRB/IEC should
conduct continuing review of each ongoing trial at intervals
appropriate to the degree of risk to human subjects, but at
least once per year.
What is the minimum number of members for an IRB/IEC?
And what specific people need to be involved? Correct
Answer (a) At least five members.
(b) At least one member whose primary area of interest is
in a nonscientific area.
(c) At least one member who is independent of the
institution/trial site.
What four things should the investigator promptly report to
the IRB/IEC? Correct Answer (a) Deviations from, or
changes of, the protocol to eliminate immediate hazards to
the trial subjects.
, (b) Changes increasing the risk to subjects and/or
affecting significantly the conduct of the trial.
(c) All adverse drug reactions (ADRs) that are both serious
and unexpected.
(d) New information that may affect adversely the safety of
the subjects or the conduct of the trial.
For how long should the IRB/IEC retain all relevant
records? Correct Answer The IRB/IEC should retain all
relevant records for a period of at least 3-years after
completion of the trial and make them available upon
request from the regulatory authority(ies).
Who is ultimately responsible for the investigational
product accountability at the site? Correct Answer The
investigator.
What records should be maintained regarding
investigational product? Correct Answer The investigator
or pharmacist or other appropriate individual, who is
designated by the investigator/institution, should maintain
records of the product's delivery to the trial site, the
inventory at the site, the use by each subject, and the
return to the sponsor or alternative disposition of unused
product(s). These records should include dates, quantities,
batch/serial numbers, expiration dates (if applicable), and
the unique code numbers assigned to the investigational
product(s) and trial subjects. Investigators should maintain
records that document adequately that the subjects were
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 TUTORWAC. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $20.99. You're not tied to anything after your purchase.