Janus

The Janus is a data repository for subject-level clinical and nonclinical study data submitted to FDA as part of a regulatory submissions. Janus supports a transparent, consistent, and efficient scientific review process by performing automated extraction, transformation, loading, management, and integration of data to facilitate regulatory review.

Janus Delivers Data to Reviewers

The Janus conceptual model is informed by the Biomedical Research Integrated Domain Group (BRIDG) Domain Model (see http://www.bridgmodel.org/). Janus is designed to receive data in CDISC SDTM[1] format and can support other emerging study data exchange standards, such as HL7 v3, FHIR,[2] and RDF.[3] Standardized study data submitted to FDA should adhere to the study data validation rules published on the Study Data Standards Resources page.

Janus development remains iterative, and we expect the model to evolve as new requirements emerge and alternative solutions are considered.

[1] Clinical Data Interchange Standards Consortium, Study Data Tabulation Model; see http://www.cdisc.org

[2] Health Level Seven version 3 and Fast Healthcare Interoperability Resources; see http://www.hl7.org

[3] Resource Description Framework; see http://www.w3.org/RDF

For more information contact OCSServiceDesk@fda.hhs.gov.

For Industry

Janus

Related Information

More in Study Data Standards