Foundations of Clinical Research and Biostatistics

Formulate a clear, testable research question using the PICO (Population, Intervention, Comparison, Outcome) framework.

Distinguish between observational and experimental study designs and describe the hierarchy of evidence.

Explain the concepts of bias and confounding and describe methods to control for them in study design and analysis.

Distinguish between categorical and continuous variables and calculate appropriate descriptive statistics for each.

Explain the principles of statistical hypothesis testing, including p-values, Type I/II errors, and confidence intervals.

Select an appropriate statistical test (e.g., t-test, chi-square test) for comparing two groups and interpret the results.

Explain the importance of effect size in conjunction with statistical significance.

Describe the core ethical principles governing human research, including informed consent, beneficence, and justice.