CEOUT: Variable not recommended for use

Pinnacle 21 Support SDTM
1

Dear Olga,

Are you sure about “CG0467”? CG0467 is “–STDTC not present” (see “conformance rules” at SDTM | CDISC).

The authors of the SDTMIG never meant wording like "variable XXX is not recommended for use in domain YY" or “The following Qualifiers would not generally be used in YY” to be implemented in validation software as a warning. Also, if you look into the rules developed and published by CDISC (see link above), you will never find such a rule.
If it is an FDA/PMDA rule, than it appears due to that (external) consultants to the FDA/PMDA strongly overinterpreted the SDTMIG. The rule should just not be there.

With best regards,

Jozef
CDISC volunteer and developer for over 18 years

2

Hi Jozef,

Appreciate your attention to my question.

You are right, warning appears under SDTM-IG 3.2 (FDA) configuration on Pinnacle 21 Community version 1903.1.
Thank you for clarifying!

3

Hi Olga,

This rule is based on SDTM-IG text in section 6.2:

"Additional Events Qualifiers
The following Qualifiers would generally not be used in CE: --SER, --ACN, --ACNOTH, --REL, --RELNST, –OUT, --SCAN, --SCONG, --SDISAB, --SDTH, --SHOSP, --SLIFE, --SOD, --SMIE."

Kind Regards,

Sergiy

4

Hi SDTM Experts,

CEOUT produced Warning: SD1075 CG0467 Variable not recommended for use. SDTM IG has example where CE.CEOUT (example #4 under FA section). Also, per SDTM v1.5, --OUT are acceptable in Events Observation Class.
Could you please shed some light if this check is not applicable to CE?

Thank you in advance.