Glossaries
Glossaries
| Term | Definition |
|---|---|
| Janus study data repository |
The Janus is a data repository for subject-level clinical and nonclinical study data submitted to FDA as part of a regulatory submission. NOTE: Sometimes written as JANUS, the term is not an acronym. [FDA Study Data Standards]
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| Janus conceptual model |
A logical design for a data warehouse intended to integrate submission data, protocol descriptions, and analysis plans from clinical and animal studies into an FDA review environment that uses a set of validated, standards-based tools to allow reproducible cross-study, data mining, and retrospective comparative analysis. [FDA Study Data Standards]
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