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Serious Adverse Event SAE Report Form NCCIH

Serious Adverse Event SAE Report Form NCCIH

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[Music] hi and welcome back to our gcp mindset channel and all topics on clinical research today we will talk about serious adverse event reporting for investigators more after the break serious adverse event should be reported within 24 hours what are serious adverse events watch our other video the investigators should report all known information associated with the serious adverse event even if new insights emerge after the serious adverse event notification a time frame of 24 hours is required for follow-up serious adverse event reports serious adverse events should be reported by the investigator to the drug safety department of the sponsor the death of a subject should in any case be reported to the ethics committee regardless of the cause also serious adverse events influencing the benefit risk profile of a study must be reported to the ethics committee and the sponsor should in any case keep a record of each individual serious adverse event when reporting serious adverse event

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