Study Phases, Background of Clinical Trials 1200-SPCTA-wstep
The lecture consists of an introduction to the topic of clinical trials, during which the history and basics of clinical trial regulation are presented. After the introduction, students complete a first task in groups on the milestones of clinical trial regulation. The next part of the lecture is devoted to eight sections of good clinical practice, the first section – glossary, the second section – the principles of good clinical practice, the third – the duties of the bioethics committee, the fourth – the duties of the principal investigator, the fifth – the responsibilities of the sponsor, the sixth – the clinical trial protocol, the seventh – the investigator's brochure, the eighth – the documentation necessary for the clinical trial. The final part is devoted to the phases of clinical trials, their types and characteristics. Students complete the Quiz task by matching the appropriate phase of the clinical trial to the description. Students receive a clinical trial protocol, created for postgraduate studies, and complete tasks related to the Matthiola protocol.
Learning outcomes
Has in-depth knowledge of the history of clinical trials in Poland and in the world, the purpose of regulating clinical trials, has advanced knowledge of the most important directions of development and guidelines for conducting clinical trials, has in-depth knowledge of the principles of operation of companies carrying out clinical trials on commission (CRO), Knows the various stages of the trial from the start-up phase to the closure of the trial, Knows and understands the specifics of non-commercial clinical trials, in particular the trends of changes taking place on this market, Knows the most important documents and forms necessary to conduct a clinical trial, Knows the purpose and requirements of keeping clinical trial documentation, Knows the principles of GMP in the extended scope, the various stages of drug development (from the development of the molecule to the introduction of the drug to the market), Knows the obligations of the sponsor and the investigator in the conduct of clinical trials, Knows the rules for storing the investigational drug, Knows the rights and obligations incumbent on the trial site conducting the clinical trial, Knows the rules and requirements for the informed consent process of the patient – GCP and international requirements, Knows the rights and obligations incumbent on the sponsor conducting the 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
ICH E6 (R2) Good clinical practice - Scientific guideline | European Medicines Agency (europa.eu)
Additional information
Additional information (registration calendar, class conductors, localization and schedules of classes), might be available in the USOSweb system: