History

In March 2004, the Federal Adverse Event Task Force (FAET) headed by the Director of NIH's Office of Biotechnology Assessment, was formed in the wake of the Department of Health and Human Services Secretary's Advisory Committee on Human Subjects Protections (SACHRP). It includes representatives of the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, U.S. Food and Drug Administration (FDA), Office of Human Research Protection (OHRP), the Department of Defense (DoD), and the Department of Veterans Affairs (VA), all of which are ex official members of SACHRP, with the goal of streamlining and coordinating the currently diverse Federal requirements for the reporting and review of adverse events.

The participating agencies created a new harmonized data model, Basal Adverse Event Report (BAER), which was validated using NIH Gene Modification Clinical Research Information System (GeMCRIS) adverse event report. After successful validation, the BAER Model was accepted as the underlying technical base data model for the new cross-agency adverse event reporting portal, called Safety Reporting Portal (SRP). SRP has the ability to transform and submit BAER data into message formats such as E2B, HL7, and BAER, to downstream systems.