Evaluation of overall compliance and performance of safety (AE, ADR, SAE, SUSAR) 1200-SPCTA-ocena
The lecture is devoted to the characteristics of adverse events and their classification. Discussion of the types of adverse events and the rules for their reporting according to GCP rules and local law.
Learning outcomes
Knows the most important documents and forms necessary to conduct a clinical trial; Knows the purpose and requirements of keeping clinical trial records; Knows and understands national and international regulations related to conducting a clinical trial and a medical experiment, Knows the rights and obligations incumbent on the sponsor conducting a clinical trial, Knows the concepts of AE, SAE, SUSAR in a clinical trial along with an indication of the differences between them, Understands the requirements for monitoring visit reports and troubleshooting in clinical trials. Knows the applicable procedures related to the monitoring and reporting of adverse reactions in a clinical trial, Knows the systems and platforms used to conduct, report and analyse data in the clinical trial process.
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: