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ACRP-CP EXAM NEWEST ACTUAL EXAM STUDY GUIDE QUESTIONS AND DETAILED CORRECT ANSWERS | A+ GRADE
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ACRP-CP EXAM NEWEST ACTUAL EXAM STUDY GUIDE QUESTIONS AND DETAILED CORRECT ANSWERS | A+ GRADE
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ACRP-CP EXAM NEWEST ACTUALEXAM 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
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