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Cards In This Set
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The International Conference on Harmonization (ICH) does not include the following members:
The European Union (EU)
South America
The United States
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South America
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What is the minimum number of Institutional Review board (IRB) members?
3
5
6
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5
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The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new dosage would be?
91
100
77
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77
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The responsibility for ensuring that the investigator understands a clinical trial lies with
The FDA
The IRB
The Sponsor
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The Sponsor
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Significant risk device is defined as an investigational device that is:
a. Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject
b. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety or welfare of a subject
c. For a use of substantial importance in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety or welfare of a subject.
d. all of the above
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D. all of the above
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