SD0094: EPOCH in DS should be null for Protocol Milestone

Pinnacle 21 Product Suggestions Validation Rule Suggestions
1

Hi Joan,

Yes, you are correct. It’s a valid SDTM compliance rule. It has been already implemented as a check SD1115.

Thank you,

Sergiy

2

in the latest releases of the validator.

3

The SDTM I.G. for 3.1.2 (and in the update for 3.1.3) has DS domain examples showing “OTHER EVENT” (dscat) records populated with the EPOCH nonnull. See p. 108, with Other Event of dsdecod=TREATMENT UNBLINDED, dscat=OTHER EVENT and nonnull EPOCH=TREATMENT PHASE. The example was not changed for 3.1.3.

Other examples show EPOCH as null for dscat of PROTOCOL MILESTONE.

It seems that SD0094 could be changed, from “Category for Disposition Event (DSCAT) should equal ‘DISPOSITION EVENT’, when Epoch (EPOCH) is provided” to > DSCAT should NOT equal 'PROTOCOL MILESTONE" when Epoch (EPOCH) is provided.

Do you think such a rule would better match the intent of the I.G. Interested in your view.

Thank you very much.

Joan Berger