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(SAE)
IRBSOP019
2023/3/27
06
1 23 1.
(SAE)
2.
2.1 (Adverse event)
2
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Gather all necessary information about the serious adverse event, including the date of occurrence, details of the event, and any factors that may have contributed to it.
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What is serious adverse events in?
Serious adverse events (SAEs) are any untoward medical occurrences that result in death, are life-threatening, require hospitalization, cause disability or permanent damage, or are related to a significant medical event.
Who is required to file serious adverse events in?
Sponsors of clinical trials, healthcare professionals, and institutions involved in clinical research are typically required to file serious adverse events.
How to fill out serious adverse events in?
To fill out serious adverse events, one must complete a standard reporting form that includes patient identification, details of the adverse event, its seriousness, and causality assessments.
What is the purpose of serious adverse events in?
The purpose of reporting serious adverse events is to monitor participant safety, assess the risk associated with a treatment, and provide timely information to regulatory authorities.
What information must be reported on serious adverse events in?
Information that must be reported includes a description of the event, the dates it occurred, the patient's condition, the treatment administered, and any relevant history.
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