Research methods |
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Define a study question
State a research hypothesis
Conduct a comprehensive literature review
Assess the appropriateness of published research methods
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Biostatistics |
Levels of measurement/data types
Descriptive/Inferential/Non-parametric statistics
Hypothesis testing
Power analysis
Commercially available programs
Advanced statistics (correlation/regression, survival curves)
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Literature evaluation |
Types of published literature
Systematic method of evaluating primary literature
Criteria for assessing cause-effect relationship for adverse drug reactions
Criteria for assessing literature on efficacy of drug treatment
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Application of research methods and biostatistics to a patient case
Identify knowledge gaps based on interpretation of the literature
Interpret data in figures and graphs
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Research ethics |
Institutional review boards and informed consent
HIPAA (covered entities)2
Good Clinical Practice
Ethical principles of research
Animal research regulations
FDA3 regulations (drug & device)
Special populations (children, women, prisoners)
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Identify when IRB1 approval is required
Delineate required from optional consent elements
Discuss inappropriate research conductance
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