Audits and Regulatory Inspections 1200-SPCTA-audyt
The lecture is devoted to the characteristics of the closing visit. The objectives and requirements of the close-out 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, the students, working individually, write a report from the close-out visit based on the review of the source documentation.
Learning outcomes
Knows the rights and obligations incumbent on the research site conducting a clinical trial, Knows the rules and conduct of selection, initiation, monitoring, closing visits, Uses English-language specialist vocabulary (English at B2+ level) in the field of clinical trials in business contacts. Demonstrates readiness to solve and resolve crisis situations during the implementation of a clinical trial. Knows the rules related to the processing of personal and sensitive data in a clinical trial and medical experiment. Formulates hypotheses and verifies them at the stage of writing reports on clinical trial visits. Knows the principles of GMP in the extended scope, the individual stages of drug development (from the development of the molecule to the introduction of the drug to the market). Knows the rules of storage of the investigational drug. Knows the purpose of inspections and audits and the purpose of maintaining the quality of clinical trials, Formulates hypotheses and verifies them at the stage of writing reports on clinical trial visits, Creates a report on the implementation of studies as well as audits and monitoring visits, Implements appropriate remedial actions in the event of fraud, falsification and low quality in clinical trials, Establishes international contacts in the field of clinical trials and scientific research.
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: