ACRP CP CERTIFICATION EXAM NEWEST
2024-2025 ACTUAL EXAM COMPLETE 150
QUESTIONS AND CORRECT DETAILED
ANSWERS (VERIFIED ANSWERS)
|ALREADY GRADED A+
A site is in the start-up phase of an industry-sponsored phase 3
trial: and has received IRB/IEC approval. The site can begin
enrolling subjects after - CORRECT ANSWER-a signed clinical
trial agreement between the site and sponsor is in place.
In a multi-arm: randomized clinical trial: one arm of the protocol
was terminated due to an increased risk of breast cancer in the
subjects. Who is responsible for providing a written report to the
IRB/IEC? - CORRECT ANSWER-PI
Part of a sponsor's responsibility pertaining to electronic trial
data handling is to maintain an audit trail: data trail: and edit
trail. Which entity is primarily charged with considering subject
rights and well-being during clinical trials? - CORRECT
ANSWER-Institutional Review Board (IRB)/Independent Ethics
Committee (IEC)
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Which of the following would be considered a vulnerable
population requiring special consideration by an IRB/IEC? -
CORRECT ANSWER-1. Medical, pharmacy, dental, and
nursing students:
2. Prisoners
3. Serving military personnel
T or F- The terms "serious" and "severe" are synonymous
according to ICH - CORRECT ANSWER-False
An Unexpected Adverse drug reaction is - CORRECT
ANSWER-A reaction that is not consistent with the applicable
product information
ICH safety definitions can be found in - CORRECT ANSWER-
ICH E2A
An Adverse Event (AE) that is severe in intensity - CORRECT
ANSWER-May not meet the definition of serious
T or F- Information discovered during the course of a clinical
investigation that might materially influence the benefit-risk
assessment of the investigation/product may necessitate rapid
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communication to regulatory authorities. - CORRECT
ANSWER-True
Subject 3826 had to stay in the hospital for three extra days
when his legs started swelling after participation in a cardiac
drug study. Swelling of the legs was listed in the Investigator's
Brochure as a possible side effect. This is considered a/an -
CORRECT ANSWER-Serious Adverse Drug Reaction
T or F- A subject in your diabetes research study developed
colon cancer: which the Investigator has determined to be
unrelated to the study. The subject is currently asymptomatic.
This will be considered a serious adverse event because it is life
threatening. - CORRECT ANSWER-False
In pre-market approval studies: all noxious and unintended
responses to a medicinal product even possibly related to any
dose should be considered - CORRECT ANSWER-Adverse
Drug Reaction
You were just informed that you have a research patient that is
receiving intensive treatment in an emergency room for allergic
bronchospasm. This should be considered as - CORRECT
ANSWER-A serious adverse event
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After a Serious Adverse Event (SAE) has occurred: how should
you list the subject identification on the immediate and follow-
up reports? - CORRECT ANSWER-By their subject
identification number
In which scenario would unblinding typically occur? -
CORRECT ANSWER-When the investigator wants to make
sure a particular subject is not randomized to placebo in the case
of a Serious Adverse Event (SAE)
What is the timeframe for "expedited" reporting of serious: fatal
or life-threatening: unexpected adverse drug reactions to
regulatory authorities? - CORRECT ANSWER-As soon as
possible, but no later than SEVEN calendar days after first
knowledge of the event
The term "severe" in ICH is used to describe - CORRECT
ANSWER-The Intensity of a specific event
All cases judged by either the reporting health care professional
or the sponsor as having a reasonable suspected causal
relationship to the medicinal product qualify as - CORRECT
ANSWER-Adverse Drug Reactions
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