Relevant Study Systems (EDC, IRT, CTMS, e-LAB) 1200-SPCTA-system
The lecture is devoted to the characteristics of systems used in clinical trials. The main principles of operation of the eCRF, IRT, CTMS, eTMF, ePRO, e-LAB systems are discussed. The lecture ends with an oral test to check the understanding of the difference between the systems. The principles of cooperation with vendors/service providers are presented. The aim of the lecture is to discuss the scope of work and key points that should be included in the scope of work. Students complete the assignment in groups and create a scope of work for the clinical trial protocol.
Learning outcomes
Knows the most important documents and forms necessary to conduct a clinical trial; Knows the responsibilities of the sponsor and the investigator in the field of conducting clinical trials, Knows the systems and platforms used to conduct, report and analyze data in the clinical trial process, Uses IT systems and software used in clinical trials. has advanced knowledge in the most important directions of clinical trial development. Has advanced knowledge of clinical trial guidelines. Knows the different stages of the study from the start-up phase to the closure of the study. Has in-depth knowledge of the principles of operation of companies carrying out contract clinical trials (CRO). Knows the most important documents and forms necessary to conduct a clinical trial. Knows and understands global, European and national legal regulations related to the registration of a trial and obtaining the consent of the relevant authorities and the bioethics committee. Consciously supervises and is responsible for the quality and safety of clinical trials. Delegates tasks and manages the time of conducting research and monitoring work.
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
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