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Warning message SD1278 when TSPARAMCD="TCNTRL", TSVAL="NONE", TSVALCD=C41132 with SDTM CT: 2020-06-26

c Catherine
 on September 8, 2020

 

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

SD1278.PNG

Forums: SDTM

Sergiy
on September 8, 2020
P21

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
P21

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
P21

Hi Sophie, 

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

Kind Regards,
Sergiy

 

 

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