Fundamentals of Epidemiology: What is epidemiology? History of Epidemiology, Emergence of modern epidemiology, Measures of Exposures, Types of exposures, Sources of exposures, Measures of outcome, disease registries, Classification of diseases.
Clinical study Designs: Clinical research process and Health research ethics. Experimental and observational studies: Randomized and non-randomized studies. , Intervention studies, Cohort studies, case-control studies, cross-sectional studies, ecological studies, Measures of exposure effect, relative and absolute measures of effect, Confidence intervals and significance tests for measures of occurrence and effect.
Design and conduct of clinical trials: the need and ethics of clinical trials, Drug Development Process, ICH GCP, Relevant FDA and EMEA guidelines (Industry, TA-, phase-specific), data management, objectives and end points of clinical trials, bias and random errors in clinical studies, conduct of clinical trials, overview of phase I-IV trials, multi-center trials. Design of clinical trials: parallel vs cross-over designs, cross-sectional vs: longitudinal designs. Design and analysis of Phase - I, Phase -II and Phase-III trials.