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Division of Microbiology and Infectious Diseases SAE Recording and Reporting Guidelines for Vaccine Studies CROSS PVG SAE Hotline 1-800-537-9979 (US) or 1-301-897-1709 (Outside US) CROSS PVG SAE Fax
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Who needs sae forms - niaid:

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Researchers and scientists conducting clinical trials or studies funded by the National Institute of Allergy and Infectious Diseases (NIAID) may need to fill out sae forms.
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SAE forms (Serious Adverse Event forms) for NIAID are used to report serious adverse events that occur during clinical trials sponsored or funded by the National Institute of Allergy and Infectious Diseases.
Researchers and institutions conducting clinical trials under NIAID sponsorship or funding are required to file SAE forms to report any serious adverse events.
To fill out SAE forms for NIAID, researchers must provide detailed information about the adverse event, including the patient's information, description of the event, relationship to the study intervention, and any actions taken.
The purpose of SAE forms for NIAID is to ensure that serious adverse events are reported and monitored to evaluate the safety of clinical trials and protect patient welfare.
SAE forms must report details such as the nature and severity of the adverse event, the onset date, the outcome, actions taken, and any relevant medical history.
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