ACRP CCRA TEST 2025/2026 BANK 2
VERSIONS CURRENTLY TESTING
COMPLETE EXAM QUESTIONS WITH
DETAILED VERIFIED ANSWERS
EXPERT VERIFIED /ALREADY GRADED
A+
You're a CRA looking for a site to conduct a phase II trial.
What should you be looking for to ensure the site is able to
conduct the trial successfully? - ....ANSWER...- Sufficient
resources to ensure patient safety
- Sufficient resources (staff, materials, financial) to conduct
the required interventions as per protocol
- Ability to collect data on therapeutic efficacy, dosage, and
other trial-specific goals
A site struggles with the conduct of a phase III trial due to
lack of site staff to be able to conduct all visits and collect
required data as identified in the protocol. Upon
completion, the investigator tells the CRA and site staff
,during a follow-up meeting that she no longer wants to
conduct trials because of the resource challenges they
faced. What would you recommend the investigator do? -
....ANSWER...Evaluate available resources (staff, time,
patient population, financial) and conduct trials in phase
for which the site has resources.
What's the difference between phase III and IV trial? -
....ANSWER...- Phase IV usually requires more subjects
and data collection than Phase III
- Phase III usually has fewer subjects and follow-up visits
than Phase IV
True or False? An investigator claims he can conduct the
Phase II trial without issues as he's already conducted ten
Phase III and IV trials. - ....ANSWER...False
WhWhich type of trial will most likely be used in a Phase
I? - ....ANSWER...Dose-response trial
Concept that refers to sensitivity of overall conclusions to
various limitations of data, assumptions, analytic
approaches and data analysis. - ....ANSWER...Robustness
,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
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
VERSIONS CURRENTLY TESTING
COMPLETE EXAM QUESTIONS WITH
DETAILED VERIFIED ANSWERS
EXPERT VERIFIED /ALREADY GRADED
A+
You're a CRA looking for a site to conduct a phase II trial.
What should you be looking for to ensure the site is able to
conduct the trial successfully? - ....ANSWER...- Sufficient
resources to ensure patient safety
- Sufficient resources (staff, materials, financial) to conduct
the required interventions as per protocol
- Ability to collect data on therapeutic efficacy, dosage, and
other trial-specific goals
A site struggles with the conduct of a phase III trial due to
lack of site staff to be able to conduct all visits and collect
required data as identified in the protocol. Upon
completion, the investigator tells the CRA and site staff
,during a follow-up meeting that she no longer wants to
conduct trials because of the resource challenges they
faced. What would you recommend the investigator do? -
....ANSWER...Evaluate available resources (staff, time,
patient population, financial) and conduct trials in phase
for which the site has resources.
What's the difference between phase III and IV trial? -
....ANSWER...- Phase IV usually requires more subjects
and data collection than Phase III
- Phase III usually has fewer subjects and follow-up visits
than Phase IV
True or False? An investigator claims he can conduct the
Phase II trial without issues as he's already conducted ten
Phase III and IV trials. - ....ANSWER...False
WhWhich type of trial will most likely be used in a Phase
I? - ....ANSWER...Dose-response trial
Concept that refers to sensitivity of overall conclusions to
various limitations of data, assumptions, analytic
approaches and data analysis. - ....ANSWER...Robustness
,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
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
