Janus clinical trial data repository is a

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

data repository (or

data warehouse In computing, a data warehouse (DW or DWH), also known as an enterprise data warehouse (EDW), is a system used for Business reporting, reporting and data analysis and is considered a core component of business intelligence. DWs are central Repos ...

) standard as sanctioned by the

U.S. Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

(FDA). It was named for the

Roman god Roman mythology is the body of myths of ancient Rome as represented in the literature and visual arts of the Romans. One of a wide variety of genres of Roman folklore, ''Roman mythology'' may also refer to the modern study of these representat ...

Janus (mythology) In ancient Roman religion and myth, Janus ( ; la, Ianvs ) is the god of beginnings, gates, transitions, time, duality, doorways, passages, frames, and endings. He is usually depicted as having two faces. The month of January is named for Janu ...

, 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 The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. ...

to both look retrospectively into past clinical trials, and also relative to one or more current clinical trials (or even future clinical trials thru better enablement of clinical trial design). The Janus

data model A data model is an abstract model that organizes elements of data and standardizes how they relate to one another and to the properties of real-world entities. For instance, a data model may specify that the data element representing a car be co ...

is a

relational database A relational database is a (most commonly digital) database based on the relational model of data, as proposed by E. F. Codd in 1970. A system used to maintain relational databases is a relational database management system (RDBMS). Many relatio ...

model, and is based on

SDTM SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such a ...

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 (non-human) submission information as well, in the form of the SEND non-clinical standard. The goals of Janus are as follows: * To create an integrated data platform for most commercial tools for review, analysis and reporting * Reduce the overall cost of existing information gathering and submissions development processes as well as review and analysis of information * Provide a

common data model A common data model (CDM) can refer to any standardised data model which allows for data and information exchange between different applications and data sources. Common data models aim to standardise logical infrastructure so that related applicat ...

that is based on the SDTM standard to represent four classes of clinical data submitted to regulatory agencies: tabulation datasets, patient profiles, listings, etc. * Provides central access to standardized data, and provide common data views across collaborative partners. * Support cross-trial analyses for data mining and help detect clinical trends and address clinical hypotheses, and perform more advanced, robust analysis. This will enable the ability to contrast and compare data from multiple clinical trials to help improve efficacy and safety. * Facilitate a more efficient review process and ability to locate and query data more easily through automated processes and data standards. * Provide a potentially broader data view for all clinical trials with proper security, de-identified patient data, and proper agreements in place to share data.

External links

*https://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm155327.htm *http://gforge.nci.nih.gov/docman/?group_id=142 *http://gforge.nci.nih.gov/docman/index.php?group_id=180{{Dead link, date=January 2020 , bot=InternetArchiveBot , fix-attempted=yes *https://web.archive.org/web/20060929233205/http://crix.nci.nih.gov/projects/janus/ Databases in the United States Food and Drug Administration