Define.xml

Hi,

Thank you in advance for your help,

I'm using Community Version 4.0.2 to generate an excel spec based on our XPT files (UTF-8 and configuration SDTM-IG 3.4)

When I take this spec and import it using the define generator and select 2.0, P21 creates a define with no issue.

When using 2.1, the xml opens as plain text in the browser. 

One issue could be that the spec is still in progress. Although the 2.0 generator creates a working define using both the shell spec or a partially filled spec.

Thank you!

Hi,

We are using the latest mapping specifications from P21 community version to create define.xml using SDTM IG v 3.4. We realized that the new mapping specs template had been updated to remove the SUPPQUAL and WhereClause tabs. Is there any guidance on how to use the new mapping specifications template for generating a define.xml v 2.1?

Thanks!

Hello,

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).

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:

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!

Hello,

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,

Sandra

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?

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.

Hello,

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

This seems to be occuring within the CodeListItem elements.

Hi,

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.