6/2/25, 1:58 PM ACRP CCRC Exam Practice 2025 COMPLETE EXAM QUESTIONS AND VERIFIED ANSWERS |RECENTLY TESTING REAL EXA…
ACRP CCRC Exam Practice 2025 COMPLETE
EXAM QUESTIONS AND VERIFIED ANSWERS
|RECENTLY TESTING REAL EXAM QUESTIONS|
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Terms in this set (84)
What topic does ICH E6 GCP
cover? (Generally)
What topic does ICH E9 Statistics
cover? (Generally)
What is Intention-To-Treat All subjects in RCTs are to be observed in the trial,
principle? regardless of their compliance with the RCT.
A precise description of the treatment effect
What is an estimand? reflecting the clinical question that's posed by a trial
objective.
Events that occur during the RCT that either affect the
Intercurrent Events existence of or interpretation of measurements
associated with the clinical question of interest.
Intercurrent events are Estimand
taken into account when
calculating the ______________
?
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, 6/2/25, 1:58 PM ACRP CCRC Exam Practice 2025 COMPLETE EXAM QUESTIONS AND VERIFIED ANSWERS |RECENTLY TESTING REAL EXA…
Combining multiple variables into one variable. This
may include intercurrent events if the event itself
Composite Variable
meaningfully describes the patient's outcome (e.g.:
death).
Stratifying patients based on the potential occurrence
Principal Stratification
of an intercurrent event.
If given two treatment There would be four principal strata in this case. There
options in a study (A & B), would be individuals who don't experience the event
how many strata would on either A or B; individuals who experience the event
exist relative to the on A, but not B; individuals who experience the event
occurrence of an on B, but not A; and individuals who experience the
intercurrent event? event on both A and B.
Analyses conducted to explore the robustness of
inferences from the main estimator, deviations from its
Sensitivity Analysis
underlying modelling assumptions, and limitations in
the data.
Conducted additionally to the main and sensitivity
Supplementary Analysis
analysis to gain more insight into treatment effects.
An adaptive CT allowing for interim analyses and the
Group Sequential Design potential to stop early for efficacy or futility based on
data found (most common and practical CT)
What determines the Sample Size
primary variable in a trial?
A subset of participants who adhered to the protocol
What is the "Per Protocol"
and had no major PDs. These are the patients who
Set?
would be likely to exhibit treatment effects.
What are the other three Evaluable subjects, valid cases, and efficacy sample.
possible names for the
"Per Protocol" Set?
What is a type I error? False Positive
What is a type II error? False negative
https://quizlet.com/1050481952/acrp-ccrc-exam-practice-2025-complete-exam-questions-and-verified-answers-recently-testing-real-exam-questions-1… 2/7
ACRP CCRC Exam Practice 2025 COMPLETE
EXAM QUESTIONS AND VERIFIED ANSWERS
|RECENTLY TESTING REAL EXAM QUESTIONS|
100% SOLVED!!
Save
Terms in this set (84)
What topic does ICH E6 GCP
cover? (Generally)
What topic does ICH E9 Statistics
cover? (Generally)
What is Intention-To-Treat All subjects in RCTs are to be observed in the trial,
principle? regardless of their compliance with the RCT.
A precise description of the treatment effect
What is an estimand? reflecting the clinical question that's posed by a trial
objective.
Events that occur during the RCT that either affect the
Intercurrent Events existence of or interpretation of measurements
associated with the clinical question of interest.
Intercurrent events are Estimand
taken into account when
calculating the ______________
?
https://quizlet.com/1050481952/acrp-ccrc-exam-practice-2025-complete-exam-questions-and-verified-answers-recently-testing-real-exam-questions-1… 1/7
, 6/2/25, 1:58 PM ACRP CCRC Exam Practice 2025 COMPLETE EXAM QUESTIONS AND VERIFIED ANSWERS |RECENTLY TESTING REAL EXA…
Combining multiple variables into one variable. This
may include intercurrent events if the event itself
Composite Variable
meaningfully describes the patient's outcome (e.g.:
death).
Stratifying patients based on the potential occurrence
Principal Stratification
of an intercurrent event.
If given two treatment There would be four principal strata in this case. There
options in a study (A & B), would be individuals who don't experience the event
how many strata would on either A or B; individuals who experience the event
exist relative to the on A, but not B; individuals who experience the event
occurrence of an on B, but not A; and individuals who experience the
intercurrent event? event on both A and B.
Analyses conducted to explore the robustness of
inferences from the main estimator, deviations from its
Sensitivity Analysis
underlying modelling assumptions, and limitations in
the data.
Conducted additionally to the main and sensitivity
Supplementary Analysis
analysis to gain more insight into treatment effects.
An adaptive CT allowing for interim analyses and the
Group Sequential Design potential to stop early for efficacy or futility based on
data found (most common and practical CT)
What determines the Sample Size
primary variable in a trial?
A subset of participants who adhered to the protocol
What is the "Per Protocol"
and had no major PDs. These are the patients who
Set?
would be likely to exhibit treatment effects.
What are the other three Evaluable subjects, valid cases, and efficacy sample.
possible names for the
"Per Protocol" Set?
What is a type I error? False Positive
What is a type II error? False negative
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