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CCRP SOCRA Certification Proficiency knowledge test Exam Questions and certified Answers 2024/2025 CA$16.67   Add to cart
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CCRP SOCRA Certification Proficiency knowledge test Exam Questions and certified Answers 2024/2025
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CCRP SOCRA Certification Proficiency knowledge test Exam Questions and certified Answers 2024/2025 Define dead fetus - correct answer a fetus that exhibits neither heartbeat, respiratory activities, muscle movements or pulsations of the umbilical cord Neonate - correct answer newborn Nonvi...

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  • November 5, 2024
  • 41
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • neonate
  • dead fetus
  • nonviable neonate
  • minimal risk
  • assent
  • irb
  • 21 cfr 56
  • irbiec
  • ccrp socra certification proficiency knowledge tes

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  • CCRP SOCRA
  • CCRP SOCRA

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CCRP SOCRA Certification Proficiency
knowledge test Exam Questions and certified
Answers 2024/2025

Define dead fetus - correct answer a fetus that exhibits neither
heartbeat, respiratory activities, muscle movements or pulsations
of the umbilical cord


Neonate - correct answer newborn


Nonviable neonate - correct answer a neonate after delivery
that although living is not viable


Viable neonate - correct answer being able to survive after
delivery (given the benefit of available medical technology) to the
point of independently maintaining heartbeat and respiration


What are requirements for research on pregnant women under
45 CFR 46? - correct answer "○ For children as defined on
46.402 who are pregnant, assent and permission are obtained in
accordance with the provisions of subpart D
○ No inducements, monetary or other, will be offered to
terminate the pregnancy
○ Any possible risks is the least possible for achieving the
research
○ Direct benefit to the pregnant female
"

,Requirements for research involving neonates - correct answer
"○ This can include both viable and nonviable neonates
○ Individuals conducting the research cannot be the ones to
determine viability
○ Does not require Consent of the father or his LAR if the
pregnancy was a result of rape or incest
○ Nonviable neonates may not be involved in research unless all
of the additional conditions are met
"


What are the (5) additional conditions that need to be met for
nonviable neonates to be involved in research? - correct answer
"■ Vital functions of the neonate will not be artificially
maintained
■ The research will not terminate the heartbeat or respiration of
the neonate
■ There will be no added risk to the neonate resulting from the
research
■ The purpose of the research is the development of important
biomedical knowledge that cannot be obtained by other means
and
■ The legally effective informed consent is obtained from both
parents unless rape or incest
"


Minimal Risk - correct answer is the probability and magnitude
of physical or psychological harm that is normally encountered in
the daily lives or in the routine medical, dental, or psychological
examination of healthy persons

,Requirements for composition of IRB where prisoners are
involved - correct answer "■ A Majority of the board (except for
prisoner members) shall have no association with the prison(s)
involved, apart from their membership on the board
■ At least one member of the board shall be a prisoner
representative with appropriate background and experience to
serve in the capacity
"


What are the (6) requirements for IRB to approve research
where prisoners are involved? - correct answer "
■ Any possible advantages accruing to the prisoner through his
or her participation in the research and compensations are not at
the magnitude that his or her ability to outweigh the risk of
research against the value of such advantages in the limited
choice environment.
■ The risks involved in the research are commensurate with
risks that would be accepted by non prisoner volunteers
■ Procedures for the selection of subjects within the prison are
fair to all prisoners and immune from arbitrary intervention by
prison authorities or prisoners
■ The information is presented in language which is
understandable to the subject population
■ Adequate assurance exists that parole boards will not take into
account a prisoner's participation in the research in making
decisions regarding parole
■ Where the board finds there may be a need for follow-up
examination or care of participants after the end of their
participation, adequate provisions has been made for such
examination or care
"

, What are the (6) requirements for IRB to approve research
where prisoners are involved? - correct answer "
■ Any possible advantages through participate and
compensation are not at the magnitude that his or her ability to
outweigh the risk of research against the value of such
advantages in the limited choice environment.
■ The risks involved in the research are commensurate with
risks that would be accepted by non prisoner volunteers
■ Procedures for the selection of subjects within the prison are
fair to all prisoners and immune from arbitrary intervention by
prison authorities or prisoners
■ The information is presented in language which is
understandable to the subject population
■ Adequate assurance exists that parole boards will not take into
account a prisoner's participation in the research in making
decisions regarding parole
■ Where the board finds there may be a need for follow-up
examination or care of participants after the end of their
participation, adequate provisions has been made for such
examination or care
"


Assent - correct answer a child's affirmative agreement to
participate in research


What IRBs must register under policy 45 CFR 46 - correct
answer ○ Each IRB that is designated by an institution under an
assurance of compliance approved for federal wide use by the
office for human research protections (OHRP) and that the
research involving human subjects conducted or supported by

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