Define.xml

Hi P21 team,

I have a question regarding DD0024 and using the CT C66728 in --STRTPT variables.  Per the controlled terminology file, C66728 belongs to 'STENRF', and the SDTM v3.2 metadata released by CDISC also indicates --STRTPT variables can use STENRF.  However, when running define v2.0 using the validator (version 2.2.0), DD0024 will come up, indicating that the value ONGOING (one of the codes in CC66728) is not valid. 

I went in and checked SDTM 3.2 xml configuration and found ouf that the --STRTPT variables in the xml actually indicates e.g.

Hi,
CDSIC define xml example file indicates Predecessor variables as domain.variable, e.g. DM.ARM.

If the predecessor is from SUPP dataset how is it indicated, e.g. SUPPDM.QVAL where SUPPDM.QNAM = 'SAFETY' ? Is this machine readable ? Thanks.

A variable on a CRF with a CodeList has 3 possible terms (e.g. Mild, Moderate, Severe) but only 2 terms (e.g. Mild, Severe) occur in the dataset by the end of the trial.

In the define xml should the CodeList associated with this variable have all 3 defined terms on the CRF or only 2 terms that occur in the dataset ? Thanks.

DD0025 was not detected when I set MedDRA version as "19". I used PINNALCE21 Community 2.2.0, Define (PMDA) config. 

Is this an error ? Or, Is there any trigger data for DD0025.

      <CodeList OID="AEDIC" Name="AEDIC" DataType="text">
        <ExternalCodeList Dictionary="MedDRA" Version="19" />
      </CodeList>

In the SUPP-- Value at  Level Metadata for variable QNAM has an extra () at the end of the value in the Where column when viewing the define.html. How to get rid of the extra ()?

Hi,

I have a define.xml which looks correct however when passing through the validator I cam getting the two following messages

DD0001: Element 'MetaDataVersion' cannot have character [children], because the type's content type is element-only.
Details: Line number 7810
Define Code: </MetaDataVersion>                                                          << this line numbr 7810

Hi,

Using Pinnacle 21 Community to create a define XML the resulting define file is named "<study description>-<date/time>.XML".

Is it allowed to submit the define file named like this to FDA? Or is any specific file name required for the "define.XML" file?

Thanks and regards

Heidi

Hi,

Validating a define.xml containing two findings about datasets, FADS and FAMH, we get the error 'DD0063 Missing Alias' for both. The dataset labels are for FADS: Findings About Disposition and for FAMH: Findings About Medical History. The define.xml is created and validated using Pinnacle 21 Community.

What does this error mean and how can it be resolved?

Thanks and regards

Heidi

Hi,

I received a define.xml from a vendor, which was produced by the Pinnacle Enterprise tool.  I noticed that some of the TranslatedText elements contain microsoft curly quotes (0x92). Since this define's encoding is UTF-8, wouldn't these be invalid?  These display OK, because I assume explorer is using Windows-1252 and taking care of this for me.  I didn't get any issues in the define validator, or when I validated using the SAS XML mapper, but I think this could cause some problems down the line.  Agree?

Hi,

When validating my define.xml with CT version 2016-03-25 I get the follow error and warning I do not understand:

2 CodedValue, Code  ng/mL, C67306 DD0028  Term/NCI Code mismatch in Codelist 'PK Units of Measure' Terminology Warning

2 NCICode      C85494 DD0033  Unknown NCI Code value for Codelist 'PK Units of Measure' Terminology Error