For Industry

Janus Clinical Trials Repository (CTR)

The Janus CTR is a data warehouse for subject-level clinical trial data submitted to FDA as part of a marketing application. The repository provides FDA review staff easy access to clinical trial data to support regulatory review and to support analyses across studies that address public health and research questions as they emerge. FDA developed the repository jointly with the National Cancer Institute. The CTR has been operational at the FDA’s White Oak Data Center since January 2015.

 
FDA makes the conceptual model publicly available at no cost. The data themselves are proprietary and therefore not publicly releasable. The model is informed by the Biomedical Research Integrated Domain Group (BRIDG) Domain Model (see http://www.bridgmodel.org/). CTR 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 on fda.gov.
 
CTR development remains iterative, and we expect the model to evolve as new requirements emerge and alternative solutions are considered. 
 
 
 
Viewing the model requires the use of Enterprise Architect. A free viewer (EALitedisclaimer icon) is available for download.
 
The FDA is providing the Janus CTR conceptual model for informational purposes only. The FDA is not able to answer specific questions related to any third party implementation.   For general questions, please contact edata@fda.hhg.gov.
  
References:
A. Oliva, Janus Clinical Trials Repository (CTR): An Update; Presented at the Annual PhUSE Computational Science Symposium, March 16, 2015, Silver Spring, MD.


[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

 

Page Last Updated: 04/10/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.