Organisation and Planning: Protocol, patient selection, response Justification of  method for randomisation: Uncontrolled trials, blind trials, Placebo’s, ethical issues. The size of a clinical trial: Maintaining trials progress: Forms and data management, protocol deviations. Methods of data analysis: Binary responses, cross-over trials, survival data prognostic factors. Testing Hypothesis, Statistical Models: Inferential statistics-creating statistical hypothesis, the Z-test; designing a single variable experiment; errors in statistical decision making.  Power of test used in clinical trials/maximizing tests power. Significance testing:  t-test. Conducting two-way experiments and trials. Interpreting  overall results of Clinical Trials. Nonparametric Procedures/Tests & Ranked Data: , Mann-Whitney U test, Kruskal-Willis, Friedman.