SAETRS
The Serious Adverse Event Tracking and Reporting System (SAETRS) provides Principal
Investigators, Study Coordinators, Site Directors, Medical Monitors and NIDA personnel
a tool to document, track, and report serious adverse events that occur in any
NIDA-sponsored clinical study. The application allows input of initial SAE case
information, medical monitor updates and remarks to the cases as needed, and
inquiries on SAEs through pre-defined or ad-hoc reports. The SAETRS database serves
as part of a central clinical data repository supporting all clinical trials for
serious, life threatening, unexpected and intervention related diseases and conditions.
In addition, SAETRS supports the generation of reports on all SAEs that are submitted
to the FDA on a periodic basis.
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The National Institute on Drug Abuse is part of the National Institutes of Health (NIH),
a component of the U.S. Department of Health and Human Services.
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