Questions about creating and validating Define.xml

May 8, 2024



I'm working on creating Define.xml for SDTM. In codelist, I know "Decoded value" should be used as the NCI Preferred Term of CT.

However, I want to change Decoded value text different to NCI Preferred Term.


CDISC Submission Value of Code(C49568) is CM and NCI Perferred Term is "Concomitant Medication Domain". However, SDTM domain label and CRF Page name in my study is "Concomitant/Prior Medications".

So I wrote decode value as "Comcomitant/Prior Medications" of Code(C49568).

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February 29, 2024

Dear all,

as I am new to the whole CDISC concept, may I ask for the procedure to make controlled terms visible in the "Controlled Terms or ISO Format" column in define.xml? Codelist sheet of define spec excel contains all neccassary values..


All the define.xml previews which can be found via google include some data:

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February 27, 2024

Dear all,

according to the Define-XML specification, the allowable values for "type" in MethodDef Element are "Computation" and "Imputation". The description for type is "Computation is intended to describe an algorithm to populate a value; Imputation is the process of replacing missing data with substitute values."

However, I never saw a Define where type="Imputation" was used (not even in the CDISC examples). Could you please help me in which cases "Imputation" should be used?

Thanks a lot!


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February 20, 2024


Could anybody explain the rationale/source documentation for the checks DD0109:Inconsistent Origin for USUBJID and DD0110: Inconsistent Origin for VISITNUM, I can't find any corresponding CDISC conformance rule or FDA specific requirement?

Thank you,




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February 18, 2024

What are the requirements/expectations when creating Define comments for each individual SDTM variable? I’m aware that derived variables require a comment, but are there any other expectations as to which variables need comments and what these comments need to contain? Also, is there anything that should not be included in the comments, for example raw dataset names and variables?

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January 10, 2024

Hi, I have created a SDTM define based on 2023-12-25 controlled terminology but while validating it based on Pinnacle 21 I got many issues with ID DD0033, Unknown NCI Code value for Codelist <codelist> even though it is present in Excel terminology. Some issue is with ODM.xml I guess. Because when I tried validating the define with 2023-09-29 CT I am not getting these issues.

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December 7, 2023



In a Define.xml v2.1 P21C validation we are getting DD0007 - "Invalid content was found starting with element 'Description'" output (546 rows):

P21 output 1

This seems to be occuring within the CodeListItem elements.

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October 31, 2023


I have a study using the Kellgren and Lawrence System for Classification of Osteoarthritis.

This is not part of the Controlled Terminology, so we added "KELLGREN-LAWRENCE" to CCAT (def:ExtendedValue="Yes").

As a consequence, we added a codelist for RSTEST/RSTESTCD where RSCAT = KELLGREN-LAWRENCE, and a codelist for the results RSSTRESC, following the QRS policy for the questionnaires/classifications.

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October 31, 2023


I come through a figure case for this define rule, and I would welcome any suggestion.

Here is the situation: I have the variable LBSTRESC declared globally as text, length = 9.

* where LBTESTCD = HCG, I have VLM text, length = 8 and codelist = POSITIVE/NEGATIVE.

* where LBTESTCD ne HCG, I have VLM float, length = 12.7, hence the message since "how can 12 digits fit into 9 characters?"

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October 30, 2023

When a variable is derived and has multiple methods associated with it, I have outlined the methods in the ValueLevel tab of the Excel spec with the respective where clauses. However, I am wondering what to put in the "Method" column on the Variables tab for the variable in question. Do I leave it blank or is there something I put in that column to indicate that the ValueLevel tab has the details of the derivation?

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