The Serious Adverse Event (SAE) Reporting System is focused on improving the effectiveness, efficiency, and regulatory compliance of real-time reporting of an SAE.
Improvements in these areas support compliance with the Food and Drug Administration (FDA) regulations and enhance the Command's ability to develop and deliver safe and effective medical solutions for the Warfighter.
For FDA-regulated studies, MRMC’s Clinical Trial Sponsor, PA (ACQ), must maintain the safety of subjects and they are required by law to report certain SAEs to the FDA within mandated time frames.
Overall, the goal is to support SAE tracking, classification, and reporting to the FDA.
In 2008, the eIT PMO received approval to acquire Oracle® (Phase Forward)'s SAE system to support USAMRMC. This commercial-off-the-shelf (COTS) application is called Empirica™ Trace.
SAE was put into Production in August of 2010.
More information on this module can be found on the Oracle (Phase Forward) web site. In addition, the eIT PMO has user manuals for all of the products that were purchased for USAMRMC. Please contact the eIT PMO if you would like a copy of these manuals or require additional information.
If you have additional questions, comments, and/or concerns regarding the SAE Reporting System, please contact us at email@example.com