Novinky v předkládání reportů v průběhu klinického hodnocení
Title in English | New developments in reporting during clinical trials |
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Authors | |
Year of publication | 2023 |
Type | Conference abstract |
MU Faculty or unit | |
Citation | |
Description | This paper focuses on the narrow but essential area of reporting in clinical trials, including safety reporting. It compares the content of the reports as well as possible changes in the legal deadlines following the entry into force of Regulation (EU) No 536/2014 of the European Parliament and of the Council. The main aim is to facilitate the orientation of researchers and sponsors in this area. |
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