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