SAETRS
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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