DD0033 Unknown NCI Code value for Codelist

Pinnacle 21 Support Define.xml
1

Hello Sachin,

I’m happy to help but I have a couple of questions. What Standard and Version of controlled terminology are you using to validate your define? Also can you provide an example of a codelist that is generating the issue?

Best Regards,

Gerard

2

Hi, I have exactly the same issue, was there a resolution to this issue.

My study used CTC v3.0 and my terminology sheet is per below.

Any input appreciated.

Thanks,

Matt

TOXCommon Terminology Criteria for Adverse Events V3.0C66784text11C41338Grade 1

TOXCommon Terminology Criteria for Adverse Events V3.0C66784text22C41339Grade 2

TOXCommon Terminology Criteria for Adverse Events V3.0C66784text33C41340Grade 3

TOXCommon Terminology Criteria for Adverse Events V3.0C66784text44C41337Grade 4

TOXCommon Terminology Criteria for Adverse Events V3.0C66784text55C48275Grade 5

3

Hi Matt,

What version of CDISC SDTM CT are you using for validation?

“Common Terminology Criteria for Adverse Events V3.0” C66784 Codelist was retired since version 2015-09-25.

Kind Regards,

Sergiy

4

Hi Sergiy, I was using the 26SEP2014 Codelist - and I did specify this in P21 when validating my DEFINE.

Thanks,

Matt

5

Hi Matt,

A problem is that current validation specs are limited to a single standard CT Codelist preassigned to Variable or Value-Level item. Such approach works fine for all cases except AETOXGR variable which may use either TOXGRV3 or TOXGR4 Codelists.

Now AETOXGR variable has an assignment to TOXGRV4 Codelist. The Validator does not recognize TOXGRV3 Codelist you use.

Until we will figure out a good solution, you can manually modify configuration specifications to switch from TOXGR4 to TOXGR3 Codelist.

  1. Go to components\config folder and open XML configuration file for particular standard with any TEXT or XML editor
  • For example, you can use Notepad included into MS Windows or download free Notepad++ application
  • “SDTM 3.1.3 (FDA).xml” file is configurations for SDTM 3.1.3 standard and FDA-specific checks

  1. Search for text and replaced it by

  2. Save changes and close file

  3. Re-start Validator

Here is an example for "0SDTM 3.1.3 (FDA).xml" file:

Starting on line #6252:

Standard Toxicity Grade

Edited text:

Standard Toxicity Grade

Thanks for being the first person reported this issue!

Kind Regards,

Sergiy

6

Hi,

We are getting same kind of message while validating SDTM define xml with P21 V2.1.3 [SDTM CT - 2018-03-30]. We have all CT listed values in AEACN, even getting the error message. Please suggest how to fix OR it can be considered as false positive.

Image attached for quick reference.

Thanks in Advance.

Screenshot.png
Screenshot.png1558×669 35.4 KB

7

Hi Gopalakrishna,

I cannot reproduce your case (Community 2.1.3, SDTM CT 2018-03-20, define.xml with terms from your example). My validation produced expected results with no false-positive messages from your example.

You can email your define.xml to me for further diagnostics.

Kind Regards,

Sergiy

sergiy (at) pinnacle21 (dot) com

8

Also, I would recommend to re-install SDTM CT 2018-03-30 file.

https://www.pinnacle21.com/downloads/cdisc-terminology

https://www.pinnacle21.com/configuring-pinnacle21-community-validator-cdisc-controlled-terminology

9

Hi,

We are experiencing exactly same issue (DD0033, DD0034) with all codelists.

Validator Version: pinnacle21-community-2.1.3

CDISC\SDTM Version: 2018-03-30

Validation Type: Define (PMDA) for SDTM.

Issue Happening for all Codelists in the define file.

Example: AE.ACN

Unknown NCI Code value for Codelist ‘Action Taken with Study Treatment’ –

But in define correct value is used - C66767.

Mailed details to ‘sergiy@pinnacle21.com’

10

Is there any solution the issue mentioned by Miranda.

We are facing the same with PMDA 2.1.3 with the define.xml only.

Thanks

Manolya

11

Hi,

I am using pinnacle21-community-2.1.3 validator for Define.xml and facing issue ‘Unknown NCI Code value for Codelist ‘Unit’’. My NCI code for UNIT codelist is C71620.

I am using CDISC CT 2018-06-29 where NCI code value is C71620. Could you please help why this issue is generated if the NCI code is same?

Thanks,
Aditi

12

Hi Aditi,

Information you provided is not enough for diagnostic of your issue.

Please look if this paper can be helpful? https://www.lexjansen.com/phuse/2018/si/SI07.pdf

Kind Regards,

Sergiy

13

Hi,

I am using Pinnacle 21 Version 2.1.3 to create and validate define.xml. In spite of giving correct codelists values in metadata, validator is picking this error as “Unknown NCI Code” for all codelists. The error is further related to DD0034 as well. Any suggestions to remove these or is this a bug in community tool.

Thanks.

Regards,

Sachin