Projektový management a monitoring - workshop 2025
| Title in English | Project Management and Monitoring - Workshop 2025 |
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| Authors | |
| Year of publication | 2025 |
| Type | Holding a workshop |
| MU Faculty or unit | |
| Citation | |
| Description | How to set up project management and monitoring of clinical trials so that it can withstand the new legislation and the inspection of the Czech Medical Products Regulatory Authority? The participants of our two-day training "Project Management and Monitoring", which CZECRIN organized as part of the CZECRIN Academy for teams from various hospitals across the Czech Republic, were looking for answers. During the first day, we focused on project management in an academic environment, from clinical trial legislation, through a practical demonstration of work in the CTIS portal, preparation of documentation for data management, to pharmacovigilance and regular reporting to authorities. The participants actively asked questions, they were especially interested in the practice in CTIS and the submission of interim and final reports according to the new legislation. No question was "bad" and the open atmosphere of the discussion helped significantly. Jitka Rychlíčková, Jana Unar Vinklerová, Michaela Kubelová, Karolína Grodová, Martina Kyseláková, Martina Rédová-Lojová, Martina Štorová The second day was devoted to the topic of monitoring from the manual, through CAPA and preparation for SÚKL inspections, to the implementation of First in Human studies at the center and involving patients in the design of clinical trials. It also included practical workshops focused on creating CAPA and monitoring plans, which helped participants to become aware of their own reserves and start filling them immediately. Ludmila Budova, Petr John, Michaela Hanáková, Lenka Součková & Jitka Rychlíčková The training was attended by approximately 25 experts from various hospitals. We were pleased with the evening feedback, they rated the training as very beneficial, practical and useful for their daily work in clinical research. |
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