1|Page
ACRP CP CERTIFICATION EXAM NEWEST ACTUAL EXAM
COMPLETE 100 QUESTIONS AND CORRECT DETAILED ANSWERS
(VERIFIED ANSWERS) |ALREADY GRADED A+
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
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
,2|Page
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
You are reading a Phase 2 protocol: which uses pharmacokinetic sampling
in a pediatric population with Sickle Cell Disease. Which of the following
options may be true in this scenario? - ANSWER-1. The data may better
reflect clinical use
2. This may lead to higher inter subject variability
Dosing recommendations for most medicinal products used in the pediatric
population are usually based on ________________ due to frequency of
calculation errors. - ANSWER-Mg/kg body weight
You are evaluating a pediatric protocol for a new drug. When reviewing the
drug clearance data it is important to know that hepatic and renal functions
are first mature in which of the following defined group? - ANSWER-Children
,3|Page
Non-compliance is a special problem in this age group. - ANSWER-
Adolescents
The pediatric population represents a vulnerable subgroup. Therefore:
special measures are needed to protect the rights of pediatric study
participants and to shield them from undue risk. Which of the following should
be taken into consideration? - ANSWER-1. Recruitment
2. Consent and Assent
3. Minimize risk
4. Minimize distress
During clinical development: the timing of pediatric studies will depend on -
ANSWER-1. Medicinal product
2. Type of disease being treated
3. Safety considerations
4. Efficacy and safety of alternative treatments
What does ICH E11 say about long-term surveillance of children in clinical
trials? - ANSWER-It may be needed to determine the possible effects on
development
, 4|Page
When each subject is randomized to a sequence of two or more treatments
and hence acts as their own control for treatment comparisons - ANSWER-
Crossover
When subjects are randomized to 1 of 2 or more arms: each arm being
allocated a different treatment. Each treatment will include their
investigational product at one or more doses: and one or more control
treatments: such as placebo and/or an active comparator - ANSWER-
Parallel
A sponsor is developing an IP for treatment of a medical condition where
there is one additional marketed product approved for treatment of the
condition. The sponsor believes their product works as well or better than the
current treatment with fewer side effects. What is the most-likely study design
they will use to test the efficacy of the IP? - ANSWER-Non-Inferiority
What type of clinical trial most likely requires enrollment of the largest
number of research subjects? - ANSWER-Therapeutic confirmatory (aka
Pivotal Trial: Ph III: or Comparative Efficacy)
Minimum number of membors on an IRB/IEC - ANSWER-5 (... lay people
and medical professionals can be part of the IRB/IEC)
ACRP CP CERTIFICATION EXAM NEWEST ACTUAL EXAM
COMPLETE 100 QUESTIONS AND CORRECT DETAILED ANSWERS
(VERIFIED ANSWERS) |ALREADY GRADED A+
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
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
,2|Page
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
You are reading a Phase 2 protocol: which uses pharmacokinetic sampling
in a pediatric population with Sickle Cell Disease. Which of the following
options may be true in this scenario? - ANSWER-1. The data may better
reflect clinical use
2. This may lead to higher inter subject variability
Dosing recommendations for most medicinal products used in the pediatric
population are usually based on ________________ due to frequency of
calculation errors. - ANSWER-Mg/kg body weight
You are evaluating a pediatric protocol for a new drug. When reviewing the
drug clearance data it is important to know that hepatic and renal functions
are first mature in which of the following defined group? - ANSWER-Children
,3|Page
Non-compliance is a special problem in this age group. - ANSWER-
Adolescents
The pediatric population represents a vulnerable subgroup. Therefore:
special measures are needed to protect the rights of pediatric study
participants and to shield them from undue risk. Which of the following should
be taken into consideration? - ANSWER-1. Recruitment
2. Consent and Assent
3. Minimize risk
4. Minimize distress
During clinical development: the timing of pediatric studies will depend on -
ANSWER-1. Medicinal product
2. Type of disease being treated
3. Safety considerations
4. Efficacy and safety of alternative treatments
What does ICH E11 say about long-term surveillance of children in clinical
trials? - ANSWER-It may be needed to determine the possible effects on
development
, 4|Page
When each subject is randomized to a sequence of two or more treatments
and hence acts as their own control for treatment comparisons - ANSWER-
Crossover
When subjects are randomized to 1 of 2 or more arms: each arm being
allocated a different treatment. Each treatment will include their
investigational product at one or more doses: and one or more control
treatments: such as placebo and/or an active comparator - ANSWER-
Parallel
A sponsor is developing an IP for treatment of a medical condition where
there is one additional marketed product approved for treatment of the
condition. The sponsor believes their product works as well or better than the
current treatment with fewer side effects. What is the most-likely study design
they will use to test the efficacy of the IP? - ANSWER-Non-Inferiority
What type of clinical trial most likely requires enrollment of the largest
number of research subjects? - ANSWER-Therapeutic confirmatory (aka
Pivotal Trial: Ph III: or Comparative Efficacy)
Minimum number of membors on an IRB/IEC - ANSWER-5 (... lay people
and medical professionals can be part of the IRB/IEC)
