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
format and can support other emerging study data exchange standards, such as HL7 v3, FHIR,
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 (EALite
) 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 email@example.com