define.xml file role for SDTM xpt files validation

Pinnacle 21 Support SDTM
1

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

2

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.