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15 Cards in this Set
- Front
- Back
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How is clinical researchdifferent from other research? a. Involves humans b. Involves animals c. Involves drugs d. Involves medical equipment |
a. Involves humans |
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Which one is not a clinical trial? a. Patient oriented research b. Epidemiological and behavior studies c. Maternity survey and analysis d. Inventing a new drug |
d. Inventing a new drug |
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Currently, consent documents for the general population are written at what grade level? a. 4th grade b. 8th grade c. 12th grade d. At the investigator's descretion |
b. 8th grade |
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What is the longest period in the drug development life cycle? a. Basic science research b. Pre-clinical testing c. Clinical trials d. Government approval |
c. Clinical trials |
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Why do people engage in clinical research? a. For research and excitement about the findings b. For the greater good of society c. For $$$ d. All of the above |
d. All of the above |
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Research performed looking at the effects of a new heart valve in dogs comes under... a. Pre-clinical b. Phase 1 c. Phase 2 d. Phase 3 |
a. Pre-clinical |
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Phase three clinical trials involves... a. 200+ participants and placebo b. 2000+ participants and placebo c. 200+ participants and no placebo d. 2000+ participants and no placebo |
a. 200+ participants and placebo |
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Who does the oversight for the clinical trials? a. Faculty b. Participants c. FDA d. IACUC |
c. FDA |
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One of the world's most comprehensive and effective networks of public health and consumer protections... a. The Food and Drug Act of 1906 b. Nuremberg Code 1949 c. Belmont Report 1979 d. Macbeth Act 1906 |
a. The Food and Drug Act of 1906 |
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What is IND? a. Independent researcher b. Application to FDA c. Application to drug control d. Application to IRB |
b. Application to FDA |
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IRB oversight... a. Maximizes the profit of clinical trials b. Makes better drugs c. Rights and welfare of subjects d. Approval of permits |
c. Rights and welfare of subjects |
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What is GCP? a. A way to add more cost to a project b. Standard provided by the internal conference on harmonization c. Good, clean lab practice d. Faster process |
b. Standard provided by the internal conference on harmonization |
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Informed consent process.... a. Consent document b. Active process of sharing information between study participants c. Voluntary agreement d. All of the above |
d. all of the above |
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What is clinicaltrials.gov? a. National registry for clinical trials b. Reporting for many clinical trials c. Has Section 801 or FDAAA 801 d. All of the above |
d. All of the above |
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Must report the clinical trials results no later than... a. 12 months b. 24 months c. Immediately after the study d. Immediately after analyzing data |
a. 12 months. |
