CT0081 and CT0081R false positives on SPONSOR/Clinical Study Sponsor

d Dave

on July 8, 2014

In my TS domain, OpenCDISC 1.5 with SDTM IG 3.1.3 and the CDISC CT version 2014-03-28, I'm getting CT0081 and CT0081R errors on the TSPARMCD="SPONSOR" and TSPARM="Clinical Study Sponsor" record.

The message is that the two values do not have the same code in the CDISC CT, but in fact both of them have the code C70793.

Any idea what might be going wrong with this test?

Forums: Troubleshooting and Problems

d Damon

on July 9, 2014

CT0081 and CT0081R false positives on SPONSOR/Clinical Study Spo

Dave, This is the same issue we were receiving that triggered our efforts to compare/review the latest CT files. Note that if you use any past versions of CT prior to the 12/20/2013, you shouldn't get these errors. At least that's what we found in our review. Not sure if this is helpful, but it appears that there is something going on that I at least know is not isolated.

j Joyce

on July 10, 2014

Thanks! I go the same error

Thanks!

I go the same error message for that particular code. I am using the March 2014 version of the CDISC CT.

I will reference an older version of the CT to see if it goes away.

Cheers

Joyce

m Michael

on August 28, 2014

CT0081 false positive for SPONSOR

We are looking into this.

m Michael

on August 29, 2014

Evaluator Codelist C78735

It's possible that the false positive is because CLINICAL STUDY SPONSOR exists 3 times, but not sure. looking into it

Codelist Code	Codelist Name	Code	CDISC Submission Value
C78735	Evaluator	C70793	CLINICAL STUDY SPONSOR
C66738	Trial Summary Parameter Test Code	C70793	SPONSOR
C67152	Trial Summary Parameter Test Name	C70793	Clinical Study Sponsor

s Sergiy

on October 30, 2014

There is a bug in CT0081 rule

There is a bug in CT0081 rule definition.

As a temporary solution until the next release of the validator you can edit specs manually.

Open "config-sdtm-...xml" file from "config" folder by XML or any plain text editor. Add WhereFailre="Ignore" attribute to the CT0081 and CT0081R rule defnition. E.g.,

<val:Lookup ID="CT0081" Message="TSPARM and TSPARMCD values do not have the same Code in CDISC CT" Description="In Trial Summary Dataset (TS) domain values for Trial Summary Parameter Short Name (TSPARMCD) and Trial Summary Parameter (TSPARM) variables must be populated using terms with the same Codelist Code value in CDISC control terminology. There is one-to-one relationship between TSPARMCD and TSPARM values defined in CDISC control terminology by Codelist Code value." Category="Terminology" Type="Error" Variable="VAL:DECODE == TSPARMCD" When="TSPARM != '' @and TSPARMCD != ''" Where="CodelistCode == 'C67152' @and CDISCSubmissionValue == [TSPARM]" WhereFailure="Ignore" From="FILE:CDISC:%System.ConfigDirectory%/data/CDISC/SDTM/%System.CDISC.Version%/SDTM Terminology.txt" ActiveUnless="%Variables[TSPARM].Define.WithCodeList%" />

Sorry for inconvenience.

Kind Regards,

Sergiy