ACRP CCRA EVALUATION TEST ANSWERS AND
QUESTIONS SET A+
✔✔In which trial phases would the following trial design most likely be found? An
international double-blind randomized trial comparing the efficacy of two doses of trial
drug with a commonly used competition in 50 sites recruitment of 10-30 subjects each. -
✔✔Phase III, IV
✔✔The drug 'Enhance' has been approved for marketing in wound healing in adults.
When it's on the market, the plan is to explore using it in children in the future. Which
actions should be taken? - ✔✔- A development program for use in children should be
written
- Experience with use in children so far should be collected and used in the
development plan
- Conduct pharmacodynamic/pharmacokinetic studies in children if theres no relevant
information available from similar compounds
✔✔What should be contained in study design? - ✔✔- Appropriate comparators
- Adequate numbers of subjects
- Clear endpoints
✔✔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? - ✔✔- 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? - ✔✔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? - ✔✔- 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. - ✔✔False
✔✔WhWhich type of trial will most likely be used in a Phase I? - ✔✔Dose-response trial
✔✔Concept that refers to sensitivity of overall conclusions to various limitations of data,
assumptions, analytic approaches and data analysis. - ✔✔Robustness
✔✔What is true about confirmation vs exploratory trials? - ✔✔Confirmatory trials are
intended to provide firm evidence in support claims.
✔✔What value type has components that may sometimes be analyzed separately? -
✔✔Composite
✔✔What variable type is usually a scale of ordered categorial ratings? - ✔✔Global
assessment
✔✔What variable type may not be a true predictor of the clinical outcome of interest? -
✔✔Surrogate
✔✔What design is most commonly used for confirmatory trials? - ✔✔Parallel group
✔✔What are three true statements about cross-over trials? - ✔✔- 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? - ✔✔- 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. - ✔✔True
✔✔True or False? Concluding there's no difference between two treatments when in
actual there's a difference is type II error. - ✔✔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? - ✔✔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 - ✔✔d) Equivalence margin should be same as difference observed
in superiority trials of active comparator
✔✔What techniques reduce bias? - ✔✔- 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 - ✔✔b) Double Dummy is a placebo-controlled trial
✔✔Which results of trial conduct issues have statistical impact? - ✔✔- Changes to
IC/EC
- Trialing accural rates
- Sample size adjustments
✔✔According to ICH E9, IDMCs should provide what? - ✔✔- Intervals assess the safety
of clinical trial
- Recommend to sponsor whether to continue, modify, or stop trial
✔✔Which are for full-analysis sample set? - ✔✔- 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
✔✔Which are for a per-protocol sample set? - ✔✔- Completion of pre-specified minimal
exposure to treatment is necessary
- Availability of measurements of primary variable is necessary
- No major protocol violations nor violation of entry criteria
QUESTIONS SET A+
✔✔In which trial phases would the following trial design most likely be found? An
international double-blind randomized trial comparing the efficacy of two doses of trial
drug with a commonly used competition in 50 sites recruitment of 10-30 subjects each. -
✔✔Phase III, IV
✔✔The drug 'Enhance' has been approved for marketing in wound healing in adults.
When it's on the market, the plan is to explore using it in children in the future. Which
actions should be taken? - ✔✔- A development program for use in children should be
written
- Experience with use in children so far should be collected and used in the
development plan
- Conduct pharmacodynamic/pharmacokinetic studies in children if theres no relevant
information available from similar compounds
✔✔What should be contained in study design? - ✔✔- Appropriate comparators
- Adequate numbers of subjects
- Clear endpoints
✔✔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? - ✔✔- 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? - ✔✔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? - ✔✔- 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. - ✔✔False
✔✔WhWhich type of trial will most likely be used in a Phase I? - ✔✔Dose-response trial
✔✔Concept that refers to sensitivity of overall conclusions to various limitations of data,
assumptions, analytic approaches and data analysis. - ✔✔Robustness
✔✔What is true about confirmation vs exploratory trials? - ✔✔Confirmatory trials are
intended to provide firm evidence in support claims.
✔✔What value type has components that may sometimes be analyzed separately? -
✔✔Composite
✔✔What variable type is usually a scale of ordered categorial ratings? - ✔✔Global
assessment
✔✔What variable type may not be a true predictor of the clinical outcome of interest? -
✔✔Surrogate
✔✔What design is most commonly used for confirmatory trials? - ✔✔Parallel group
✔✔What are three true statements about cross-over trials? - ✔✔- 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? - ✔✔- 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. - ✔✔True
✔✔True or False? Concluding there's no difference between two treatments when in
actual there's a difference is type II error. - ✔✔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? - ✔✔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 - ✔✔d) Equivalence margin should be same as difference observed
in superiority trials of active comparator
✔✔What techniques reduce bias? - ✔✔- 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 - ✔✔b) Double Dummy is a placebo-controlled trial
✔✔Which results of trial conduct issues have statistical impact? - ✔✔- Changes to
IC/EC
- Trialing accural rates
- Sample size adjustments
✔✔According to ICH E9, IDMCs should provide what? - ✔✔- Intervals assess the safety
of clinical trial
- Recommend to sponsor whether to continue, modify, or stop trial
✔✔Which are for full-analysis sample set? - ✔✔- 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
✔✔Which are for a per-protocol sample set? - ✔✔- Completion of pre-specified minimal
exposure to treatment is necessary
- Availability of measurements of primary variable is necessary
- No major protocol violations nor violation of entry criteria
