ACRP CCRA TEST 2025/2026 BANK 2
VERSIONS WELL RESEARCHED
CURRENTLY TESTING COMPLETE
EXAM QUESTIONS WITH DETAILED
VERIFIED ANSWERS EXPERT
VERIFIED /ALREADY GRADED A+
What is true about confirmation vs exploratory trials? -
....ANSWER...Confirmatory trials are intended to provide
firm evidence in support claims.
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
1
,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
2
,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
3
, 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
4
VERSIONS WELL RESEARCHED
CURRENTLY TESTING COMPLETE
EXAM QUESTIONS WITH DETAILED
VERIFIED ANSWERS EXPERT
VERIFIED /ALREADY GRADED A+
What is true about confirmation vs exploratory trials? -
....ANSWER...Confirmatory trials are intended to provide
firm evidence in support claims.
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
1
,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
2
,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
3
, 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
4
