DD0028 - Term/NCI Code mismatch in Codelist 'Trial Summary Parameter Test Name'

Pinnacle 21 Support Define.xml
1

Don’t do the second thing!

Never, NEVER, manipulate data or even metadata, and surely not data from officially published standards, for the sake of complying due to a bug in the validation software. It is the software that should be updated, not the define.xml. BTW, there is alternative software for define.xml validation…

2

Thank you for your valuable comment.

I searched for alternative software for define.xml validation and came up with Define.xml Checker. Is that one you are talking about?

Regards
Wick

3

Hi Wick,

It looks like you have these DD0028 messages due to your invalid execution of define.xml validation.

Versions of CDISC CT should be the same for creation of study data and for its validation.

“Standard terms” of CDISC CT are not the same across its versions.

For example, a term “Trial Disease/Condition Indication” (NCI Code=C112038) was introduced in version 2016-12-16 by replacing an original standard term “Trial Indication” (NCI Code=C112038) in previous versions.

The similar is with “Trial Intent Type” (NCI Code=C49652) which replaced the older standard term “Trial Indication Type” in version 2016-12-16.

I assume that you did not specify a correct version of CDISC SDTM CT when validating your define.xml file.

P21 Community v2.2.0 package available for downloading on P21 website includes 5 versions of SDTM CT (2015-06 / 2016-06). None of them is valid for data in your example.

Other versions require additional downloading from P21 website and installation by end-user. See https://www.pinnacle21.com/downloads/cdisc-terminology and https://www.pinnacle21.com/configuring-pinnacle21-community-validator-cdisc-controlled-terminology

Be sure that today version of CDISC CT should be consistent across all datasets within the same study. For example, you cannot use older version of CT for DM, AE or QS domains and the newest version for TS domain.

Kind Regards,

Sergiy

4

Hi Wick,

Try to re-start P21C.

Let us know if it will help?

Regards,

Sergiy

5

Hi,

I am getting error for following values with message “Term/NCI Code mismatch in Codelist ‘Trial Summary Parameter Test Name’” in validation report for Define.xml -

  1. Trial Disease/Condition Indication, C112038

  2. Trial Intent Type, C49652

Both errors have Pinnacle ID DD0028.

There are two ways I can deal with this issue.

  1. Report this as bug in SDRG.
  2. Remove their NCI Term Code from Codelists. This would report them as extended values.

Which is better approach? If there is other way, please let me know.

Thank you.

Regards,
Wick