OpenCDISC Validator checks for formats

Pinnacle 21 Support SDTM
1

Hi Cheng,

According to FDA submission data specifications SAS custom formats are not allowed.

SDTM standard does not use any standard SAS formats (with possible exceptions for numeric value formats; e.g., best7., 8.2, etc.).

In addition to numeric values formats, ADaM also utilizes SAS Date/Time formats for analysis Timing variables only.

All those checks will be available in the next OpenCDISC release in Q1 2012. There is no final decission about severity of SAS formats related checks yet.

Thank you,

Sergiy

2

Hello,

It seems that SDTM variables should not attach any sponsor defined formats. I have one senario:

  1. Define format $SEXC as M–Male, F–Female;

  2. Attach $SEXC to DM.sex varable;

  3. Send the DM (in XPT) to the OpenCDISC SDTM Validator.

How will the OpenCDISC SDTM Validator respond to sex ? Any errors or warnings (by which Rule ID) ?

Similar issues to ADaM dataset.

Thanks,

Cheng