Novinky v předkládání reportů v průběhu klinického hodnocení

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Title in English New developments in reporting during clinical trials
Authors

KUBELOVÁ Michaela

Year of publication 2023
Type Conference abstract
MU Faculty or unit

Faculty of Medicine

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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