JANUS clinical trial data repository


Janus clinical trial data repository is a clinical trial data repository standard as sanctioned by the U.S. Food and Drug Administration. It was named for the Roman god Janus, who had two faces, one that could see in the past and one that could see in the future. The analogy is that the Janus data repository would enable the FDA and the pharmaceutical industry to both look retrospectively into past clinical trials, and also relative to one or more current clinical trials.
The Janus data model is a relational database model, and is based on SDTM as a standard, in terms of many of its basic concepts such as the loading and storing of findings, events, interventions and inclusion data. However, Janus itself is a data warehouse independent of any single clinical trials submission standard. For example, Janus can store pre-clinical trial submission information as well, in the form of the SEND non-clinical standard.
The goals of Janus are as follows: