Zpráva o průběhu klinického hodnocení MEMMAT Annual Report Sledované období: 28. listopad 2023 - 26. květen 2024
Title in English | MEMMAT Report on the progress of the clinical evaluation Annual Report Monitoring period: November 28, 2023 - May 26, 2024 |
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Authors | |
Year of publication | 2024 |
Type | Research report |
MU Faculty or unit | |
web | MEMMAT |
Description | Semi-Annual reports on the progress of clinical trials describe the course of clinical trial in the observed period of time. The reports include information on screening, enrollment (number of newly enrolled patients, general overview of patients enrolled so far, number of prematurely discontinued patients), incidence of serious adverse events, identified protocol violations, information on newly identified characteristics on investigational medicinal product in relation to safety and efficacy, newly adopted measures (eg interventions of ethics committees, foreign control authorities, possible restrictive interventions of the contracting authority) and information on performed internal audits or audits by the contracting authority if applicable. |