d Dadaram
on

 

If we have a define.xml file associated with our data which type of checks will do opencdisc could you please provide me some examples? while validating the SDTM xpt file.

Forums: SDTM

s Sergiy
on December 19, 2014

Hi Dadaram, 

There are 6 OpenCDISC validation rules which compare study data vs. define.xml file. You can find them in any OpenCDISC excel report file by going to "Rules" tab and filtering "Message" column by "define" word.

Now we check consistency in 

 

  • Presence of Datasets (SD0061, SD1063)
  • Presence of Variables (SD0054, SD0060)
  • Variable Type (SD0059)
  • Codelists terms (SD0037)

 

Kind Regards, 

Sergiy

 

 

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