This course provides an introduction to clinical epidemiology, statistics, clinical trial management and data management. A brief introduction to the principles of clinical epidemiology is provided as a basis for measurement of drug effects in humans, including sources of error, types of research studies, and study design. Introduction to statistics includes methods for descriptive statistics, normal distributions and methods for expressing probability distribution parameters including t, chi-square and F. Inferential statistics covers application of distribution parameters to decision making, hypothesis testing, choosing an inferential test, comparison of two means, the two-sample t test, analysis of variance, chi-square test, correlation, non-parametric tests, and calculation of confidence intervals.
Clinical trials management reviews all stages involved in conducting a clinical trial. The stages covered include the initial project proposal; development of the protocol and other trial related documentation required to gain ethical and regulatory approval for a clinical trial; planning of all trial related materials required to commence the study; conduct of the trial during patient recruitment and treatment; data management and analysis of the data generated from the study; reporting of the data and finally close out of the trial. Responsibilities of the sponsor in trial planning, approval, investigator selection, monitoring and auditing are discussed. The International Conference on Harmonization (ICH) code of Good Clinical Practice (GCP) is emphasized throughout the module. The course is compulsory for program 7370, 5504, and 9060.