Glossary of Clinical Terms

🔴 The term “JANUS” implies both the open-source data prototype and the repository that utilizes it. It was titled after Janus, the Roman god of mythology who has two faces, one capable of seeing into the past and another capable of seeing into the future. The metaphor refers to the Janus data repository, which allows the U.S. Food and Drug Administration (FDA) and pharmaceutical firms to look back into preceding clinical study trials as well as forward into one or more ongoing clinical trials or even upcoming clinical trial studies by enabling better designs of clinical trials.

🔴 Janus facilitates a clear, coherent, and effective process of scientific review by conducting automated data extraction, transition, loading, monitoring, and data integration. The Centre for Drug Evaluation and Research (CDER) at the US FDA, will have the chance to start utilizing standard data as a result of Janus Clinical and Nonclinical. This will encourage improved analytical strategies and techniques, the formation of standard assessments and graphs, classes of drugs, and therapeutics.

🔴 Janus Clinical data service model:
Janus Clinical is defined as a repository for data pertaining to clinical trials for a particular subject that has been submitted to the FDA as a marketing application component. Janus Clinical acknowledges packages of compliant submissions from the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM).

🔴 Janus Non-Clinical data service model:
Janus Nonclinical refers to the repository of data for factual CDISC Standard for Exchange of Nonclinical Data (SEND) compliant research data received from the sponsors in aid of Investigational New Drug (IND), Biologic License Applications (BLAs), and New Drug Applications (NDAs).

The Office of Computational Science (OCS) will keep automating several steps in the process of data loading for supporting Janus as part of an overall effort to improve management of data.