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SOCRA CCRP Final Competency Certification Study Guide Exam Questions with Certified for Accuracy Answers 2024/2025 CA$18.84   Add to cart
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SOCRA CCRP Final Competency Certification Study Guide Exam Questions with Certified for Accuracy Answers 2024/2025
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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 ...

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Document information

  • November 5, 2024
  • 197
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • ich e8
  • double blind study
  • parallel group design
  • factorial design
  • crossover design
  • ich e11
  • carryover effect
  • tanner staging
  • data and safety monitoring board dsmb
  • socra ccrp final competency certificatio

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  • CCRP SOCRA
  • CCRP SOCRA

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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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