Biostatistics, Internal and Final Analysis 1200-SPCTA-biostat
The aim of the lecture is to present the basic issues of statistics in order to understand biostatistics. The lecture is devoted to the characteristics of intermediate and final analyses in clinical trials supported by statistical techniques used in clinical trials.
Learning outcomes
Uuses English-language specialist vocabulary (English at B2+ level) in the field of clinical trials in business contacts. Can prepare and evaluate documents necessary in the recruitment process of employees in the field of clinical trials. It uses IT systems and software used in clinical trials. It defines the rules for planning and organizing a clinical trial. Knows the rules of conducting the recruitment process for companies in the field of clinical trials for various positions. Has an in-depth knowledge of the principles and requirements for reporting and analysis of clinical trials. Knows advanced principles of statistical analysis. Knows the concept of endpoint in clinical trials. Has knowledge in the field of biomedical statistics in clinical trials.
Assessment criteria
Active participation in discussions, presentation of results in the forum
Bibliography
Homepage | European Medicines Agency (europa.eu)
U.S. Food and Drug Administration (fda.gov)
CT.gov: Departments and Agencies
https://www.ema.europa.eu/en/data-monitoring-committees-scientific-guideline
Additional information
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