c Catherine
on

 

Hi,

I'm get a warning message SD1278 from Pinnacle 21 report: "Inconsistent value for TSVALCD within TSVAL when TSPARMCD = TCNTRL, TSVAL = NONE and TSVALCD = C41132."

I only have a record for the TSPARMCD = TCNTRL. 

I checked CT for TSVAL = NONE that was document with Code = C41132 and Codelist Name = Control Type Response.

Not sure why I got this message and how to resolve it.

(SDTMIG : 3.2, SDTM CT: 2020-06-26, Pinnacle 21 version:  3.0.2)

Attached Files

Forums: SDTM

Sergiy
on September 8, 2020

Hi Catherine, 

My assumption is that in TS domain you have another record with TSVAL='NONE', and a missing value for TSVALCD.

Kind Regards,
Sergiy

c Catherine
on September 10, 2020


Hi Sergiy,

Yes, I have another two TSPARMCD = "STOPRULE", "STRATFCT" with TSVAL = "NONE".

Should I add TSVALCD for these two as the same as TCNTRL did?

Thank you.

Sergiy
on September 10, 2020

Yes, you should use TSVALCD consistently across all records in the domain.

c Catherine
on September 13, 2020

Thank you for your response.

s Sophie
on October 5, 2020

Hi,

Could you please perform this check only for TSVCDREF = CDISC ?

We got this error because  for a study : TSVAL = 3.2 when TSPARMCD = DOSE, and TSVAL = 3.2 when TSPARMCD = SDTIGVER.

Thanks and Regards,

Sergiy
on October 6, 2020

Hi Sophie, 

Thank you for reporting this issue! We definitely need to improve algorithm for SD1278 rule.

Kind Regards,
Sergiy

 

 

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