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.
Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.
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