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Serious Adverse Event Reporting System

SAE is the official title for the Argus Safety validated Test and Production systems. SAE is a web-based COTS application, marketed by Oracle, configured to meet the needs of USAMRDC and its Subordinate Commands. SAE is sponsored by the USAMRDC HQ Office of Regulated Activities (ORA). SAE is meant to improve the effectiveness and efficiency of real-time reporting of serious adverse events from clinical studies and safety surveillance management. It is an FDA compliant system that supports the reporting of serious adverse event data within the FDA mandated timelines.

More information on this module can be found on the Oracle site for Argus: http://www.oracle.com/us/products/applications/health-sciences/safety/argus-safety/index.html or on the Oracle Argus Safety Document Library site: https://docs.oracle.com/cd/E50011_01/index.htm. Please contact the eIT PMO if you would like access to user manuals or require additional information.

If you have additional questions, comments, and/or concerns regarding the SAE Reporting System, please contact us at usarmy.detrick.medcom-usamrmc.mbx.eit-pmo-help-desk@mail.mil

Last Modified Date: 14-January-2019