Maintenance Studies from Initiation through close out 1200-SPCTA-monitor
The lecture is devoted to the characteristics of two types of visits: selection and initiation. The objectives and requirements of the selection and initiation visits are presented. The main three stages of visits are discussed: planning and preparing for each visit, conducting the visits, and activities related to summarizing the visits. As part of the exercises, students divided into groups prepare together a presentation and an agenda for the initiation visit. Each group presents the results of the cooperation, and the other groups evaluate the presenting group.
Learning outcomes
Knows the rights and obligations incumbent on a research site conducting a clinical trial, Knows the rules and conduct of selection, initiation, monitoring and closing visits, Knows the concept of an endpoint in clinical trials, Knows the diversity of roles of individuals in conducting clinical trials, Knows the principles of cooperation in project teams. Appreciates the importance of clinical trials in the search for new drugs, in particular in terms of improving the quality of life of society, Knows the rights and obligations incumbent on a clinical trial participant, Knows the principles of cooperation in teams conducting 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
Additional information
Additional information (registration calendar, class conductors, localization and schedules of classes), might be available in the USOSweb system: