SOCRA CCRP Final Competency Certification Study Guide Exam Questions with Certified for Accuracy Answers 2024/2025
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CCRP SOCRA
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CCRP SOCRA
SOCRA CCRP Final Competency Certification Study Guide Exam Questions with Certified for Accuracy Answers 2024/2025
Per ICH E8, methods used to evaluate patient usage of the test drug should be what? - correct answer Specified in the protocol and actual usage documented
The study subject asks ...
SOCRA CCRP Final Competency Certification
Study Guide Exam Questions with Certified
for Accuracy Answers 2024/2025
Per ICH E8, methods used to evaluate patient usage of the test
drug should be what? - correct answer Specified in the protocol
and actual usage documented
The study subject asks you why the study is called a double-blind
study. You explain double blind as what? - correct answer When
the subject and the Investigator and sponsor staff who are
involved in the treatment or clinical evaluation of the subjects
are unaware of the treatment assignments
What does "DSMB" stand for? - correct answer Data Safety
Monitoring Board
True or False? The Data and Safety Monitoring Board (DSMB) is
a separate entity from an Institutional Review Board (IRB) or an
Independent Ethics Committee (IEC)? - correct answer True
What is the purpose of the "Data and Safety Monitoring Board
(DSMB)?" - correct answer To assess the progress of a clinical
trial, the safety data, and the critical efficacy endpoints
Parallel Group Design - correct answer A design in which
subjects are randomized to one of two or more arms, each arm
being allocated a different treatment
,Randomization - correct answer Introduces a deliberate
element of chance into the assignment of treatments to subjects
in a clinical trial
factorial design - correct answer a study in which there are two
or more independent variables, or factors
Data and Safety Monitoring Boards or DSMBs, have the power to
recommend which of the following? - correct answer the
sponsor should continue the trial
the sponsor should modify the trial
the sponsor should stop the trial
Primary Variable - correct answer Which variable in a study
should be used to determine the sample size?
crossover design - correct answer What do you call the clinical
trial design in which each subject is randomized to a sequence of
two or more treatments and hence acts as his or her own control
for treatment comparisons.
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? -
correct answer The target population
Carryover effect - correct answer 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.
ICH E11 - correct answer Guidance pertains to the Pediatric
Population
True or False? Due to low blood volumes researchers should not
do pharmacokinetic studies in the pediatric population. - correct
answer False
example of assent - correct answer when a child is given
information about a trial and asked if he or she wishes to
participate?
True or False? Medicinal products may affect physical and
cognitive growth and development, and the adverse event profile
may differ in pediatric patients. - correct answer True
According to ICH E11, what would the suggested age
categorization for children be if you were planning a study in
"children"? - correct answer 2 to 11 years
What are the three ways to minimize the number of samples
obtained from each pediatric patient? - correct answer Sparse
sampling
Population PK
Use of indwelling catheters
, True or False? Pharmacokinetic Phase 1 studies in the pediatric
population are generally conducted in healthy pediatric subjects.
- correct answer False
Tanner staging - correct answer The current protocol for a
study in pediatrics is asking for all new patients to have stages of
pubertal development assessed. What is this assessment called?
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?
Select all that apply - correct answer Recruitment
Consent and assent
Minimizing risk
Minimizing distress
What is the medicinal product dosing in the pediatric population
usually based on when developing a pediatric heart disease study
involving an adult approved drug? - correct answer Milligram
(mg)/kilogram (kg) body weight
Twenty-six subjects were enrolled in a pneumonia trial. The site
received 100 bottles of IP. Each subject receives 2 bottles. Four
subjects did not return their trial bottles. How many bottles are
available for the CRC to return to the sponsor at the end of the
trial? - correct answer 92
At the month-3 visit of a Phase III double-blind trial, the subject
informs the CRC that he was seen in the emergency department
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