Articles

Therapeutic Area User Guides (TAUGs) contain many useful examples, but it can be hard to find a useful example since there are over 40 TAUGs, and many TAUGs include examples that are useful outside a particular therapeutic area. The spreadsheet classifies TAUG examples by domain, so if a user has data that would be represented in a particular domain, the spreadsheet can identify TAUGs that might have examples relevant to their data. 

Standard(s): CDASH, SDTM, SDTMIG
Novice

In the diagrams below, the red line represents a graph of severity over time for a hypothetical event. For most adverse events, severity cannot be measured on a continuous scale; this line represents hypothetical actual severity, not data that could be recorded. The horizontal lines divide severity into the three categories, "Mild", "Moderate", and "Severe", which are used to describe adverse event severity.

Standard(s): CDASH, SDTM, SDTMIG
Intermediate

CDISC has published the first of a new kind of QRS supplement to the SDTMIG, a supplement for an oncology response criterion, Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

Standard(s): SDTMIG
Intermediate

This article provides information on the ISO international standard for country codes is ISO-3166, which provides several representations of names for countries (ISO-3166-1) and their subdivisions (ISO-3166-2).

Standard(s): SDTMIG
Novice

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 intended to include all units of measure currently used internationally in science, engineering and business and has been adopted internationally by IEEE, DICOM, LOINC, and HL7, and is also in the ISO 11240:2012 standard.

Intermediate