BRIDG & FDA

BRIDG & FDA

​As a BRIDG stakeholder, the US Food and Drug Administration (FDA) has been the owner or sponsor of several models harmonized with BRIDG over the years. These projects include the following:

  • FDA Common Data Model Harmonization (CDMH) Model - a BRIDG-based model used to provide patient-centered outcomes researchers with access to broader observational data by leveraging existing networks: ACT/i2b2, OMOP, PCORnet, and Sentinal
  • FDA Clinical Trials Repository (CTR/Janus)
  • HL7 Individual Case Safety Report (ICSR) Message
  • CDISC HL7 Study Design Message (partial)
  • CDISC HL7 Study Participation Message
  • Adverse Events Model
  • HL7 Regulated Product Submission (RPS) Message