Types of Visits 1200-SPCTA-wizyt
The lecture is devoted to the characteristics of the monitoring visit. The objectives and requirements of the monitoring visit were presented. The main three stages of visits are discussed: planning and preparation for each visit, conducting visits and activities related to the summary of visits. As part of the exercises, students work individually in the eCRF system and enter data from the source documentation into the system.
Learning outcomes
Knows the rights and obligations incumbent on a research site conducting a clinical trial, Knows the rules and conduct of selective, initiating, monitoring, closing visits, Knows the concept of endpoint in clinical trials, Knows the diversity of roles of individual people in conducting clinical trials, Knows the principles of cooperation in project teams. Understands the requirements for monitoring visit reports and troubleshooting in clinical trials. It uses IT systems and software used in clinical trials. Demonstrates readiness to solve and resolve crisis situations during the implementation of a clinical trial.
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: