Janus Clinical Trials Repository (CTR) Project
The FDA, in close collaboration with the National Cancer Institute Center for Biomedical Informatics and Information Technology (NCI CBIIT), is developing a standards-based repository of subject level clinical trial data to support regulatory review and patient centered outcomes research (PCOR).
Development of the CTR is committed to open-source, open-access software and tools with the goal of promoting the maximum amount of sharing with industry. With that in mind, we are making the current conceptual model publicly available. The conceptual model captures FDA’s requirements for clinical trial data. The model is informed by the Biomedical Research Integrated Domain Group (BRIDG) Domain Model (see http://www.bridgmodel.org/) and is designed to receive data in CDISC SDTM format and emerging HL7 v3 study data exchange standards.
CTR development remains iterative, and we expect the model to evolve, perhaps greatly, as testing progresses, new requirements emerge, and alternative solutions are considered.
[Note: Viewing the model requires the use of Enterprise Architect. A free viewer (EALite ) is available for download
At this time, 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 Bobbie Witczak and Robyn Barringer.