Safety reporting requirements for inds and BA BE studies
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- 1Suspected unexpected serious adverse reaction (SUSAR)
Definition: Any unfavourable occurrence in a trial participant that is judged to have a major imp...
- 2SUSAR – Suspected Unexpected Serious Adverse Events ...
- 3SUSAR – Suspected Unexpected Serious Adverse Events ...
SUSAR expedited reporting is one of the core PrimeVigilance services. We provide the facility to ...
- 4臨床試驗中未預期之嚴重藥品不良反應
若經評估後該不良事件屬於未預期之嚴重藥品不良反應(SUSAR),試驗主持人除告. 知藥廠或臨床試驗委託公司外 ... Definitions and Standards for Expedite...
- 5Safety monitoring and reporting for clinical trials in Europe
Serious Unexpected Serious Adverse Reactions (SUSARs) ... Definition of Adverse Reaction ... expe...