Clinical data is data pertaining to actual observation and treatment of patients.
CDISC SDTM : Model
CDSIC Define XML : Metadata
General classes of observations on subjects I,E,F : Interventions, Events, Findings
General structures : Identifiers, Topic variables, Timing variables, qualifiers
Model : wraps the observations
Domain : series of observations
- Identifier variables – identify the study, the subject. domain, sequence number
- topic variables (name of the test)
- timing variables (start and end date)
- qualifier variables (numeric units)
- rule variables (algorithim)
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). The Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC) defines SDTM.