Safety Reporting Portal
Announcement

Update: Secure Your Account Security with Multi-Factor Authentication (MFA)

In response to a recent executive order aimed at account security and safeguarding sensitive information, we're thrilled to introduce Multi-Factor Authentication (MFA) for all user logins. Effective June 30th, 2024, you will be required to activate MFA when logging in. This additional security measure adds an extra layer to the login process, ensuring that only authorized users can access their accounts, even in the event of a compromised password.

Enabling MFA is simple and quick! Just follow the standard login procedure to set it up. Your email address will serve as the means to receive a secure 6-digit passcode, which expires after 120 seconds. Please ensure that you use valid email accounts.

Your security is of utmost importance to us, and we remain dedicated to providing you with the most secure online experience possible. We appreciate your cooperation in helping us maintain a secure environment for all users.

Should you have any inquiries or require assistance, please do not hesitate to contact our support team.

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.