Incorrect TSVAL/TSVALCD validation

t Thierry

on January 16, 2015

Hi,

I am validating a submission with OC 2.0. The submission uses SDTMIG 3.1.3 & Define 2.0. I get a series of messages about invalid TSVAL/TSVALCD values, that are wrong:

First type of message:

CT2004/FDAC343 TSVALCD value not found in 'Intervention Type' non-extensible codelist

The offending value is TSVALCD = C1909, which is correct for TSVAL = DRUG (controlled terminology INTTYPE). After investigating your configuration files, I found that you define the same codelists for TSVAL and TSVALCD, which is wrong per SDTMIG, which states that TSVALCD stores the NCI Concept Id when TSVCDREF=CDISC. This is admittedly bizarre, but TSVAL=TSVALCD also makes little sense.

Second type of message:

SD2250/FDAC261 Invalid TSVAL value for CURTRT
SD2251/FDAC262 Invalid TSVALCD value for CURTRT

Here, both TSVAL and TSVALCD are null, but TSVALNF = NA, so these messages should not appear.

Best regards,
-- Thierry

Forums: Troubleshooting and Problems

s Sergiy

on January 23, 2015

Hi Thierry, Thank you for

Hi Thierry,

Thank you for reporting these bugs!

Thery are already fixed and corrected version will be availabe in the next Auto-Update release.

Kind Regards,

Sergiy

j Joan

on January 26, 2015

Hi Sergiy, does the TS correction cover these similar issues?

1) Similar findings for TSVALCD of SEXPOP (e.g., code asssigned to 'BOTH'), and of STYPE, INTMODEL, TBLIND, TCNTRL, TDIGRP (at least for 'HEALTHY SUBJECTS', C49651), TPHASE, and TTYPE.

2) Also, the values for treatments using UNII coding draw warning flags that these are being compared to a 'Treatment Failure Reason' extensible codelist, which seems to be the wrong codelist, e.g., for tsparmcd='TRT'. The compare match brings up a message about this for "TSVAL value" (the drug name), and then another message about it for TSVALCD value (the unii code).

Thank you.

- Joan