TS domain SD1226:Missing INDIC Trial Summary Parameter

m Martina

on July 26, 2016

Hi All,

For the TS domain we get an error for rule ID1226 “Missing INDIC Trial Summary Parameter”.

This parameter is not required according SDTM IG 3.2.

Please refer to SDTM IG: TS – Assumptions for Trial Summary Information Dataset - point 15.

Can you please clarify what the issue is? Does the implemented rule need to be adapted?

Thanks for any feedback.

Kind regards,

Martina

Forums: SDTM

c Carlo

on July 26, 2016

See table in TS section, Example 1

While not called out as clearly as it could be, Example 1 lists "all parameters that are required or expected" and INDIC is included. This is born out indirectly in Assumption 15, showing the null flavor usage when INDIC is not applicable.

I'll check to see if this is already called out for the 3.3 changes, and if not, propose the table reference in Example 1 be be included under the assumptions for TS to identify required/expected parameters.

Another issue is that the null flavor a may not be taken into account by the validator. If that is the case, you can document in the SDRG.

Regards,

Carlo