Projektový management a monitoring II. workshop 2024
| Title in English | Project Management and Monitoring II. Workshop 2024 |
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| Authors | |
| Year of publication | 2024 |
| Type | Workshop |
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| Description | The workshop was intended for all those who want to engage in clinical trials, especially in academic and non-profit organizations. The event was implemented with the organizational support of the Pharmaround Foundation and guaranteed by ČAS - Czech Nurses Association. Program: December 2, 2024 PROJECT MANAGEMENT Project management and clinical trial legislation CTIS portal and preparation of documents for submission of documentation - initial submission, amendments, transfer Submission of reports during and after the completion of the clinical trial Preparation of documentation for data management, communication with the project manager and monitor, data exports Pharmacovigilance Practical exercises December 3, 2024 MONITORING General introduction to monitoring in clinical trials Monitoring manual, CAPA Monitoring issues - practical experience SÚKL inspection Implementation of First in Human studies from the center's perspective Practical exercises |
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