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- Vital signs may be collected using either a normalized or a denormalized horizontal data structure, depending on the functionality of the data management or data capture system being used.
- In a denormalized structure, vital signs are collected using a unique variable name for each test, resulting in a wide, horizontal dataset with multiple test results in each record. The SDTMIG VS structure is normalized, using 1 variable (VSTEST) for the name of the test and 1 variable (VSORRES) for the collected results, resulting in a vertical data structure in which there is 1 record for each test/result. CDASH recommendations are intended to facilitate moving denormalized data to the SDTM normalized data structure, because standard transformation programming can be written when the variable naming syntax is consistent and uses CDISC root variables and Controlled Terminology.
- The set of variables needed for a particular study may include only test result and result unit, or may include other variables such as location, laterality, position, or method. The examples in this section different ways that denormalized variable names can be created based on the general variable-naming rules of CDASH, using the root variables found in the CDASH Model in combination with the controlled terminology from the Vital Signs Test Code codelist (VSTESTCD) in a consistent syntax.
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