Study Start-up Activities from site identification through Pre-initiation 1200-SPCTA-aktywn
At the beginning of the lecture, students receive information on the requirements that should be met by the EMEA region, the EU country and the research center in order to properly conduct a clinical trial. Strategies for selecting a region, country, and study site to conduct a clinical trial are discussed. The exercises are devoted to defining a strategy for identifying study sites by checking whether the site meets the eligibility criteria for a clinical trial. On the basis of the analysis of the descriptions of the five potential research centers, the students complete the eligibility forms and decide on the selection of research centers for the Matthiola clinical trial.
The lecture is devoted to the characteristics of the requirements for submitting a clinical trial in Europe and in Poland. Discussion of the institutions and criteria for submitting a clinical trial in Europe and Poland. A description of the new rules for submitting clinical trials according to EU-CTR, the required documentation and the time frame. During the exercises, students complete tasks related to the submission of a clinical trial in accordance with the regulations.
Learning outcomes
He 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. He 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 the purpose and requirements of keeping clinical trial records. Knows the rules for submitting applications and their processing by bioethics committees. Knows the purpose and requirements of keeping clinical trial records. Knows the rules for submitting applications and their processing by bioethics committees. 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. Knows the responsibilities of the sponsor and the investigator in conducting clinical trials. Knows and understands national and international regulations related to conducting clinical trials and medical experiments. Is familiar with the current and planned legislative solutions for concluding mandatory third-party liability insurance for the researcher and the sponsor. Knows the rules related to the processing of personal and sensitive data in a clinical trial and medical experiment. It defines the rules for planning and organizing a clinical trial. It applies regulations related to the protection of personal and sensitive data. Respects the rights of patients and other participants in clinical trials.
Assessment criteria
Active participation in discussions, presentation of results at 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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