CRKAS EXAM QUESTIONS |GUARANTEED ACCURATE
ANSWERS |LATEST VERSION 2025\26 |COMPLETE
Terms in this set (50)
True or false? Direct False
communication between a
sponsor and IRB/IEC is
expressly prohibited per GCP.
,As part of their risk assessment e) A &B Only
process the sponsor determines
that there is a high likelihood
that enrollment in the trial will
be challenging and slow. Which
of the following is the best
choice in this situation:
a.The sponsor should develop a
risk management plan to
handle this operational risk
b.The sponsor should develop
a proactive recruitment
strategy to mitigate the risk
of low
enrollment
c.The sponsor should outsource
the trial to a CRO to ensure
enrollment success
d. All of the above
e.A and B only
,In considering whether or not to a) True
approve a clinical trial, the
IRB/IEC should consider the
qualifications of the investigator
via review of a current
curriculum vitae or other
documentation.
a.True
b. False
c. It depends - only if the
IRB/IEC hasn't worked with the
investigator in the past
Which of the following a.The Nuremberg Code
documents has/have influenced b.The Declaration of Helsinki
the ethical principles within the
current GCP guidelines?
Multiple Answers
a.The Nuremberg Code
b.The Declaration of Helsinki
c.The Paris Report
, All of the following are elements g
or principles of human
subject
protection EXCEPT a. Voluntary,
informed consent b. Respect for
persons: treated as autonomous
agents c. The right to end
participation in research at any
time d. Right to safeguard
integrity e. Benefits should
outweigh risk f. Protection from
physical, mental, and
emotional harm
g. The primary care
physician can overrule the
subject's decision to
participate in a trial
h. Access to information
regarding research i. Protection
of privacy and well-being
True or False? One benefit of True
transparent reporting of trial
results is that it enables the
reader to judge the reliability
and validity of trial results.
ANSWERS |LATEST VERSION 2025\26 |COMPLETE
Terms in this set (50)
True or false? Direct False
communication between a
sponsor and IRB/IEC is
expressly prohibited per GCP.
,As part of their risk assessment e) A &B Only
process the sponsor determines
that there is a high likelihood
that enrollment in the trial will
be challenging and slow. Which
of the following is the best
choice in this situation:
a.The sponsor should develop a
risk management plan to
handle this operational risk
b.The sponsor should develop
a proactive recruitment
strategy to mitigate the risk
of low
enrollment
c.The sponsor should outsource
the trial to a CRO to ensure
enrollment success
d. All of the above
e.A and B only
,In considering whether or not to a) True
approve a clinical trial, the
IRB/IEC should consider the
qualifications of the investigator
via review of a current
curriculum vitae or other
documentation.
a.True
b. False
c. It depends - only if the
IRB/IEC hasn't worked with the
investigator in the past
Which of the following a.The Nuremberg Code
documents has/have influenced b.The Declaration of Helsinki
the ethical principles within the
current GCP guidelines?
Multiple Answers
a.The Nuremberg Code
b.The Declaration of Helsinki
c.The Paris Report
, All of the following are elements g
or principles of human
subject
protection EXCEPT a. Voluntary,
informed consent b. Respect for
persons: treated as autonomous
agents c. The right to end
participation in research at any
time d. Right to safeguard
integrity e. Benefits should
outweigh risk f. Protection from
physical, mental, and
emotional harm
g. The primary care
physician can overrule the
subject's decision to
participate in a trial
h. Access to information
regarding research i. Protection
of privacy and well-being
True or False? One benefit of True
transparent reporting of trial
results is that it enables the
reader to judge the reliability
and validity of trial results.
