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AX1V2/SOP09/V2 SERIOUS ADVERSE EVENT REPORT BBC Projects NO: Regulated by CGI: CTI Reg. No:Yes / NOAA per ICH GCP: Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) is any
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NIA adverse event refers to adverse events associated with the National Institute on Aging (NIA) research studies or clinical trials.
Researchers, clinical trial sponsors, and healthcare providers involved in NIA research studies are required to file NIA adverse event reports.
NIA adverse event reports can be filled out electronically through the designated reporting system provided by the NIA or by submitting the required forms via email or mail.
The purpose of NIA adverse event reporting is to monitor and assess the safety and efficacy of interventions or treatments being studied in NIA research projects.
Information such as the nature of the adverse event, date of occurrence, severity, relationship to the study intervention, and actions taken in response to the event must be reported on NIA adverse event forms.
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