ACRP CCRC FINAL EXAM 2024
ACTUAL EXAM 300 QUESTIONS WITH
DETAILED VERIFIED ANSWERS (100%
CORRECT ANSWERS) /ALREADY
GRADED A+
What value type has components that may
sometimes be analyzed separately? -
....ANSWER...Composite
What variable type is usually a scale of ordered
categorial ratings? - ....ANSWER...Global assessment
What variable type may not be a true predictor of the
clinical outcome of interest? -
....ANSWER...Surrogate
What design is most commonly used for
confirmatory trials? - ....ANSWER...Parallel group
,What are three true statements about cross-over
trials? - ....ANSWER...- The subjects are their won
control
- The drug being studied is highly variable
- Some subjects start on treatment arm A and other
on treatment arm B or C
What are the main reasons for having multicenter
trials? - ....ANSWER...- Timeframe for recruitment
- Possibility of generalization of results
True or False? Concluding that theres a difference
between two treatments when in actual fact there is
no different is type 1 error. - ....ANSWER...True
True or False? Concluding there's no difference
between two treatments when in actual there's a
difference is type II error. - ....ANSWER...True
When doing a trial with purpose to generate data to
get marketing approval for generic product by
comparing it to original product, which type of trial
would be the type to choose? -
....ANSWER...Equivalence
,Which statement about equivalence margin is NOT
true?
a) The equivalence margin should be specified in
protocol
b) The equivalence margin is the largest difference
that can be judged as being clinically acceptable
c) Equivalence is inferred when entire confidence
interval falls within equivalence margin
d) Equivalence margin should be same as difference
observed in superiority trials of active comparator -
....ANSWER...d) Equivalence margin should be same
as difference observed in superiority trials of active
comparator
What techniques reduce bias? - ....ANSWER...-
Blinding
- Randomization
Which is NOT true about Double Dummy trials?
a) Double Dummy may be single-blind or double-
blind
, b) Double Dummy is a placebo-controlled trial
c) Double Dummy enables blinding for products that
have different physical appearance
d) Double Dummy enables blinding for products
which have different administration schedule -
....ANSWER...b) Double Dummy is a placebo-
controlled trial
Which results of trial conduct issues have statistical
impact? - ....ANSWER...- Changes to IC/EC
- Trialing accural rates
- Sample size adjustments
According to ICH E9, IDMCs should provide what? -
....ANSWER...- Intervals assess the safety of clinical
trial
- Recommend to sponsor whether to continue,
modify, or stop trial
Which are for full-analysis sample set? -
....ANSWER...- Includes all randomized subjects
- Complete follow-up of all randomized subjects for
study outcomes if necessary
- Most likely to mirror normal day to day practice
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