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Hi,

 

Based on Define V2.1 origin for SDTM dataset, please help to discuss the type of --STRESU for VS, LB,EG domain and so on, if the standard unit was not collected in the CRF. Here are 2 options, "Derived" or "Assigned"? Moreover, how about other ambiguous variables, such as AVISITN/PARAMCD/PARAMN?How to distinct the type of "Derived" or "Assigned"? Thanks!

Option 1: TYPE as "Derived". Follow the Define-XML-2-0-Specification.pdf as below, the type of VSSTRESU is "Derived".

VSSTRESU from Define-XML Specification Document Version 2.0

 

 

 

 

 

 

 

 

 

 

 

 

 

Option 2: TYPE as "Assigned". Follow the example from Define V2.1 as below.

define v2.1

Forums: Define.xml

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