A substance administration consists of a substance and the activity of administering the substance. Some data items describe the substance, others the administration.   In…

A query about adverse events is, at heart, an observation.   Data on the adverse event may also include location and pattern. This concept map…

  LOINC is a pre-coordinated laboratory coding system used in healthcare IT systems. It includes lab tests, clinical measures, HIPAA documents and standardized survey instruments….

SDTM describes several types of datasets. This diagram illustrates a hierarchical view of those types of datasets. Findings domains may be represented as findings about…

  Unified Code for Units of Measure (UCUM) was developed by Regenstrief Institute and the UCUM Organization as an unambiguous system of units and their combinations. UCUM is…

PHUSE US Connect 2019 Paper SI08 Considerations for Using CDISC Standards in Observational Studies Jon Neville, CDISC, Austin, TX, USA Bess LeRoy, CDISC, Austin, TX,…

Data about medical history and prior meds are often collected at an initial study visit. Records in an SDTM-based dataset for these events and interventions…

The terms “domain” and “dataset” are commonly used in CDISC’s nomenclature and found frequently in the Study Data Tabulation Model (SDTM). For example, the SDTM…

Background When development of the SDTM and SDTMIG started, SAS was in almost universal use in the pharmaceutical industry and at FDA. "The SAS® Version…

SNOMED (short for SNOMED Clinical Terms or SNOMED CT) is a set of medical terms used widely in clinical practice. Some have asked why CDISC…