ACRP CP CERTIFICATION EXAM 2024
ACTUAL EXAM COMPLETE
ACCURATE EXAM QUESTIONS WITH
DETAILED VERIFIED ANSWERS (100%
CORRECT ANSWERS) /ALREADY
GRADED A+
Your Investigator wants to participate in a Phase 3
Pharmacokinetics study. Pharmacokinetic studies
are commonly conducted in later phases to answer
what questions? - ....ANSWER...1. Food effects on
bioavailability
2. Information in sub-populations such as patients
with impaired elimination
3. Drug to drug interactions
A trial where the treatment assignment is not known
by the study participant because of the use of
placebo or other methods of masking the
intervention: but the study team knows -
....ANSWER...Single blind
,A new study is investigating a new IND "glue" that
can be used to hold skin cuts together and decrease
the chance of scaring. You know children should be
included because ICH E8 considers them a special
population. In designing the protocol you should
expect to - ....ANSWER...Include children in the
general plan from the beginning
Per ICH E8: methods used to evaluate patient usage
of the test drug should be - ....ANSWER...Specified in
the protocol and actual usage documented
Which trial design is used for the specific purpose of
examining the interaction of A and B? -
....ANSWER...Factorial design
T or F- The Data and Safety Monitoring Board
(DSMB) is a separate entity from an Institutional
Review Board (IRB) or an Independent Ethics
Committee (IEC)? - ....ANSWER...True
What is the purpose of the "Data and Safety
Monitoring Board (DSMB)?" - ....ANSWER...To assess
,the progress of a clinical trial: the safety data: and
the critical efficacy endpoints
T or F- The focus of ICH E9 is on statistical
principles: however: it does not address the use of
specific statistical procedures or methods. -
....ANSWER...True
For a randomized trial: the following is true -
....ANSWER...1. The procedure to be followed: the
necessary documentation: and the subsequent
treatment and assessment of the subject should all
be described in the protocol
2. Helps to avoid possible bias in the selection and
allocation of subjects arising from the predictability
of treatment assignments
Data and Safety Monitoring Boards (DSMBs) have
the power to recommend which of the following? -
....ANSWER...1. That the sponsor should continue the
trial
2.That the sponsor should modify the trial
3. That the sponsor should stop the trial
, You need to maintain the blind in a clinical study.
Which of the following options might you use when
administering supplies in the clinical trial? -
....ANSWER...Double-dummy
Which variable in a study should be used to
determine the sample size? - ....ANSWER...Primary
variable
You are writing an Investigator-initiated clinical
research protocol and you need to limit the
occurrence of conscious and unconscious bias.
Which of the following methods may be used? -
....ANSWER...1. Single-Blind
2. Masking
3. Double-Blind
You are reading the findings of a clinical trial on hair
loss and use of shampoo. You note in the final
analysis that data was extrapolated from the
subjects who participated in the trial to a broader
patient population and a broader range of clinical
settings. This is known as -
....ANSWER...Generalization
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