ACRP- Clinical Research Knowledge Assessment (CRKA) with Questions and Answers
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Module
Acrp
Institution
Acrp
ACRP- Clinical Research Knowledge Assessment (CRKA) with Questions and Answers
True or false? Direct communication between a sponsor and IRB/IEC is expressly prohibited per GCP. ANSWER False
As part of their risk assessment process the sponsor determines that there is a high likelihood that e...
ACRP- Clinical Research Knowledge Assessment (CRKA) with Questions and Answers
True or false? Direct communica tion between a sponsor and IRB/IEC is expressly prohibited per GCP. ANSWER False
As part of their risk assessment 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 ANSWER e. A and B only
In considering whether or not to 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 ANSWER a. True
Which of the following documents has/have influenced the ethical principles within the current GCP guidelines?
a. The Nuremberg Code b. The Declaration of Helsinki
c. The Paris Report
d. A and B ANSWER d. A and B
All of the following are elements 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 ANSWER g. The primary care physician can overrule the subject's decision to participate in a trial
True or False? One benefit of transparent reporting of trial results is that it enables the reader to judge the reliability and validity of trial results. ANSWER True
True or False? One important distinction between standard of care medical treatment and clinical research is that the intent of medical treatment is to address the needs of an individual
patient in the here and now, whereas clinical research is intended to answer questions about whether a treatment or procedure could benefit large groups of people in the future? ANSWER True
True or False? According to local law, Investigators should immediately report SAEs to the sponsors and IRB/IEC followed by detailed written reports within a timely fashion. ANSWER True
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