CPI EXAM QUESTIONS AND
ANSWERS; 100% PASS
GUARANTEED; GRADED A+
________________ may inevitably be created between
the subject and the PI due to therapeutic misconception.
This is created by both thinking that the clinical research's
primary aim is to benefit the subject. - correct
answer- Ethic tension.
_________________ is intended to limit the occurrence of
conscious and unconscious bias in the conduct and
interpretation of a clinical trial arising from the influence
which the knowledge of treatment may have on the
recruitment and allocation of subjects, their subsequent
care, the attitudes of subjects to the treatments, the
assessment of end-points - correct answer-
Blinding or masking
____________________ is an event occuring after
treatment start that may complicate interpretation of
,treatment effects during statistical analysis. - correct
answer- intercurrent affects
________________________is a type of research
methodology that allows for the investigation of the main
and interaction effects between two or more independent
variables and on one or more outcome variable(s) -
correct answer- Factorial design
______________is an international ethical and scientific
quality standard for designing, conducting, recording and
reporting trials that involve the participation of human
subjects. Compliance with this standard provides public
assurance that the rights, safety, and well-being of trial
subjects are protected, consistent with the principles that
have their origin in the Declaration of Helsinki, and that
the clinical trial data are credible.
A) Belmont Report.
B) Good Clinical Practice (GCP)
C) Nurnburg Code
D) 45 FDA E6 (R2) - correct answer- B) Good
Clinical Practice (GCP)
,__________regulations state that applications for devices
must include all forms and informational materials to be
provided to subjects to obtain ICF. The sponsor
(MAY/MAY NOT) begin investigation until these material
are apporved. - correct answer- Investigational
Device Exemption (IDE)
________are events that can occur once the treatment
has started, affect the presence and/or interpretability of
the observed variable, and are not bound to the trial
setting (for example, treatment discontinuation due to
toxicities, use of emergency medication). - correct
answer- Intercurrent Events (ICEs)
_______defines how well the sample we've analized
represnts the whole population. - correct answer-
Confidence Interval
______(A)_________ design is an experimental study
design in which each subject is randomized to one of two
or more distinct treatment/intervention groups. Those
who are assigned to the same treatment are referred to
, as a _________(B)__________. - correct answer-
A) A parallel group B) treatment group
"A design in which subjects are randomized to one of two
or more arms, each arm being allocated a different
treatment" is a description of what kind of trial design?
A) Crossover design
B) Factorial design
C) Parallel Group design
D) Multicenter design - correct answer- C
A 10-year-old child who reads well is asked to participate
in a clinical research trial for a non-life-threatening
condition. He reads the assent form given to him and
decides not to participate in the study. What should the
research professional do?
A) They should have the child talk to his doctor about his
concerns.
B) They should not enroll the child in the study.
C) they should encourage the child's parents to convince
the child to assent.
ANSWERS; 100% PASS
GUARANTEED; GRADED A+
________________ may inevitably be created between
the subject and the PI due to therapeutic misconception.
This is created by both thinking that the clinical research's
primary aim is to benefit the subject. - correct
answer- Ethic tension.
_________________ is intended to limit the occurrence of
conscious and unconscious bias in the conduct and
interpretation of a clinical trial arising from the influence
which the knowledge of treatment may have on the
recruitment and allocation of subjects, their subsequent
care, the attitudes of subjects to the treatments, the
assessment of end-points - correct answer-
Blinding or masking
____________________ is an event occuring after
treatment start that may complicate interpretation of
,treatment effects during statistical analysis. - correct
answer- intercurrent affects
________________________is a type of research
methodology that allows for the investigation of the main
and interaction effects between two or more independent
variables and on one or more outcome variable(s) -
correct answer- Factorial design
______________is an international ethical and scientific
quality standard for designing, conducting, recording and
reporting trials that involve the participation of human
subjects. Compliance with this standard provides public
assurance that the rights, safety, and well-being of trial
subjects are protected, consistent with the principles that
have their origin in the Declaration of Helsinki, and that
the clinical trial data are credible.
A) Belmont Report.
B) Good Clinical Practice (GCP)
C) Nurnburg Code
D) 45 FDA E6 (R2) - correct answer- B) Good
Clinical Practice (GCP)
,__________regulations state that applications for devices
must include all forms and informational materials to be
provided to subjects to obtain ICF. The sponsor
(MAY/MAY NOT) begin investigation until these material
are apporved. - correct answer- Investigational
Device Exemption (IDE)
________are events that can occur once the treatment
has started, affect the presence and/or interpretability of
the observed variable, and are not bound to the trial
setting (for example, treatment discontinuation due to
toxicities, use of emergency medication). - correct
answer- Intercurrent Events (ICEs)
_______defines how well the sample we've analized
represnts the whole population. - correct answer-
Confidence Interval
______(A)_________ design is an experimental study
design in which each subject is randomized to one of two
or more distinct treatment/intervention groups. Those
who are assigned to the same treatment are referred to
, as a _________(B)__________. - correct answer-
A) A parallel group B) treatment group
"A design in which subjects are randomized to one of two
or more arms, each arm being allocated a different
treatment" is a description of what kind of trial design?
A) Crossover design
B) Factorial design
C) Parallel Group design
D) Multicenter design - correct answer- C
A 10-year-old child who reads well is asked to participate
in a clinical research trial for a non-life-threatening
condition. He reads the assent form given to him and
decides not to participate in the study. What should the
research professional do?
A) They should have the child talk to his doctor about his
concerns.
B) They should not enroll the child in the study.
C) they should encourage the child's parents to convince
the child to assent.
