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ACRP CP FINAL EXAM 2025/2026/ACRP CP CERTIFICATION EXAM
NEWEST COMPLETE ALL 250 QUESTIONS AND CORRECT
DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY GRADED A+
You need to maintain the blind in a clinical study. Which of the following
options might you use when administering supplies in the clinical trial? -
ANSWER-Double-dummy
Which variable in a study should be used to determine the sample size? -
ANSWER-Primary variable
You are writing an Investigator-initiated clinical research protocol and you
need to limit the occurrence of conscious and unconscious bias. Which of
the following methods may be used? - ANSWER-1. Single-Blind
2. Masking
3. Double-Blind
You are reading the findings of a clinical trial on hair loss and use of
shampoo. You note in the final analysis that data was extrapolated from the
subjects who participated in the trial to a broader patient population and a
broader range of clinical settings. This is known as - ANSWER-
Generalization
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The Investigator at your site asked you to review a protocol. The
investigational product listed in the protocol already has proven clinical
benefits for the disease under study. This is considered what type of trial? -
ANSWER-Confirmatory Trial
You are designing a cross-over study. Cross-over designs have a number of
problems that can invalidate their results. The chief difficulty concerns
__________: that is: the residual influence of treatments in subsequent
treatment periods. - ANSWER-Carryover effect
Missing data points (values) represent a potential source of bias in a clinical
trial. (True or False) - ANSWER-True
What study variable takes in the consideration the decision making process
of the treating physician: who must weigh benefit and risk in making product
use decisions. - ANSWER-Global Assessment Variable
True or False- You are working on a Phase 1 clinical trial. The sponsor tells
you that the study will be carried out in three different research centers. Multi-
center trials can be carried out at any stage of clinical development. -
ANSWER-True
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You are helping your Investigator write a protocol for a new combination of
drugs for treatment of Irritable Bowel Syndrome. Since this is an Investigator
Initiated Study you know you will need to establish a/an - ANSWER-
Independent Data Monitoring Committee
When writing an early phase clinical study plan which of the following do you
want to pay attention to if you wish to maximize the chance of observing
specific clinical effects of interest? - ANSWER-The target population
True or False- All new medications should have generated data on the use
in the pediatric population? - ANSWER-False
True or False- Medicinal products may affect physical and cognitive growth
and development: and the adverse event profile may differ in pediatric
patients. - ANSWER-True
What is it called when a child is given information about a trial and asked if
he or she wishes to participate? - ANSWER-Assent
T or F- Although initial safety and tolerability data is usually obtained in adult
trials: some products may reasonably be studied only in the pediatric
population even in the initial phases (e.g.: when studies in adults would yield
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little useful information or expose them to inappropriate risk). - ANSWER-
True
T or F- Pharmacokinetic Phase 1 studies in the pediatric population are
generally conducted in healthy pediatric subjects. - ANSWER-False
T or F- Pharmacokinetic studies in the pediatric population are generally
conducted in patients with the disease. - ANSWER-True
The two ways to minimize the number of samples obtained from each
pediatric patient are - ANSWER-1. Population PK & Sparse sampling
2. Use of indwelling catheters
T or F- It is common to extrapolate efficacy from studies in adults or even in
older pediatric patients to the preterm newborn infant to decrease the amount
of blood taken. - ANSWER-False
The current protocol for a study in pediatrics is asking for all new patients to
have stages of pubertal development assessed. This assessment is called -
ANSWER-Tanner Staging
ACRP CP FINAL EXAM 2025/2026/ACRP CP CERTIFICATION EXAM
NEWEST COMPLETE ALL 250 QUESTIONS AND CORRECT
DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY GRADED A+
You need to maintain the blind in a clinical study. Which of the following
options might you use when administering supplies in the clinical trial? -
ANSWER-Double-dummy
Which variable in a study should be used to determine the sample size? -
ANSWER-Primary variable
You are writing an Investigator-initiated clinical research protocol and you
need to limit the occurrence of conscious and unconscious bias. Which of
the following methods may be used? - ANSWER-1. Single-Blind
2. Masking
3. Double-Blind
You are reading the findings of a clinical trial on hair loss and use of
shampoo. You note in the final analysis that data was extrapolated from the
subjects who participated in the trial to a broader patient population and a
broader range of clinical settings. This is known as - ANSWER-
Generalization
,2|Page
The Investigator at your site asked you to review a protocol. The
investigational product listed in the protocol already has proven clinical
benefits for the disease under study. This is considered what type of trial? -
ANSWER-Confirmatory Trial
You are designing a cross-over study. Cross-over designs have a number of
problems that can invalidate their results. The chief difficulty concerns
__________: that is: the residual influence of treatments in subsequent
treatment periods. - ANSWER-Carryover effect
Missing data points (values) represent a potential source of bias in a clinical
trial. (True or False) - ANSWER-True
What study variable takes in the consideration the decision making process
of the treating physician: who must weigh benefit and risk in making product
use decisions. - ANSWER-Global Assessment Variable
True or False- You are working on a Phase 1 clinical trial. The sponsor tells
you that the study will be carried out in three different research centers. Multi-
center trials can be carried out at any stage of clinical development. -
ANSWER-True
,3|Page
You are helping your Investigator write a protocol for a new combination of
drugs for treatment of Irritable Bowel Syndrome. Since this is an Investigator
Initiated Study you know you will need to establish a/an - ANSWER-
Independent Data Monitoring Committee
When writing an early phase clinical study plan which of the following do you
want to pay attention to if you wish to maximize the chance of observing
specific clinical effects of interest? - ANSWER-The target population
True or False- All new medications should have generated data on the use
in the pediatric population? - ANSWER-False
True or False- Medicinal products may affect physical and cognitive growth
and development: and the adverse event profile may differ in pediatric
patients. - ANSWER-True
What is it called when a child is given information about a trial and asked if
he or she wishes to participate? - ANSWER-Assent
T or F- Although initial safety and tolerability data is usually obtained in adult
trials: some products may reasonably be studied only in the pediatric
population even in the initial phases (e.g.: when studies in adults would yield
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little useful information or expose them to inappropriate risk). - ANSWER-
True
T or F- Pharmacokinetic Phase 1 studies in the pediatric population are
generally conducted in healthy pediatric subjects. - ANSWER-False
T or F- Pharmacokinetic studies in the pediatric population are generally
conducted in patients with the disease. - ANSWER-True
The two ways to minimize the number of samples obtained from each
pediatric patient are - ANSWER-1. Population PK & Sparse sampling
2. Use of indwelling catheters
T or F- It is common to extrapolate efficacy from studies in adults or even in
older pediatric patients to the preterm newborn infant to decrease the amount
of blood taken. - ANSWER-False
The current protocol for a study in pediatrics is asking for all new patients to
have stages of pubertal development assessed. This assessment is called -
ANSWER-Tanner Staging
