EIEC - ECTS
Clinical trials are intended to answer questions about the efficacy and safety of therapeutic and preventive interventions in clinical medicine. This continuous education unit aims to provide theoretical and practical preparation necessary for the design, implementation and interpretation of results of studies on therapeutic or preventive interventions. The unit encompasses topics for design, implementation and analysis of clinical trials (phase I - phase IV). The necessary aspects will be explored for the development and execution of a study protocol, including criteria for participant selection, randomization methods, sample size determination, interventions, data analysis and interpretation and dissemination of results. The "Good Clinical Practices" (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical Products for Human Use) and the legislation of clinical trials in Portugal will also be addressed.