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 Serious Adverse Event Report Form SAE Form 2020-2025

Adverse Event Template 2020-2025 Form

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foreign [Music] clinical trials a sensitive Affair but you know what's even more sensitive essay SAE refers to Serious Adverse Events such as when a trial participant gets hospitalized suffers disability or expires during the course of a trial it puts the concerned researcher under extreme pressure such as our Dr Reddy here Dr ananya later found out that the participant died as a result of poisoning and she did not realize that it was necessary to notify the EC or the sponsor Ethics Committee temporarily suspended the clinical trial and advised Dr ananya Reddy that SAE must have been reported within 24 hours doctor approaches the head of the department for another research proposal however he is reluctant to support her because of the non-compliance in SAE reporting sir sir if you could please do you consider my Dr Reddy you need to submit the AC form and inform the Ethics Committee within 24 hours this is not acceptable so it was proven to be a case of poisoning so so what if

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