Define.xml

Hi everybody,

I was going to post that there was some trouble with validating the define file as check DD0004 (unknown attribute) fires on the OrderNumber attribute stating that it is unknown while it is part of CRT-DDS, but then I spotted that I typed it as "Ordernumber" rather than "OrderNumber" (note: n vs N).

I reran using "OrderNumber" and checked again: no more firing of DD0004.

Hello.

I am referencing MedDRA as the external codelist for all coded variables in the AE domain.  The dataype for Code Variables (eg. AELLTCD) is 'integer' where as for the term variables (eg. AELLT) the datatype is 'text' per Amendment 1 to SDTM IG 3.1.2.  When referencing the same codelist for both datatype i get the error OD0080.

Hello.

I am new to the define.xml and xml in general and not sure what this error means.  i have included 3 datasets with a total of 67 variables and 25 codelists into my define.xml which i am validating using OpenCDISC.

Please see the "Issue Summary" tab below:

Hi all,

I am asked from our customer to provide a Define.xml as PDF file for the submition to the FDA.

Have somebody experience in the transformation of the define.xml file into PDF format  ?

If yes do somebody know a tool which can perform this transformation ?

Thanks for your help,

Best regards

Frederic.

Hi,

After reading the CRT-DDS and the newly released CDSIC Metadata Submission Guidelines (MSG), I'm curious about the CodeList and its overall representation. Therefore, here are some questions that I was hoping this forum could assist with.

SD0059 Define.xml/dataset variable type mismatch

The above rule give us an error for the define.xml for any numeric data type, we have ‘Num’ in our define.xml.

Here is an example:

<ItemDef OID="BG.BGENDY" Name="BGENDY" DataType="Num" Origin="OTHER" Comment="" def:Label="Study Day of End of Weight Interval" Length="1">
</ItemDef>

In the BG.XPT file, the BGENDY is of type Numeric, In SAS xpt file, there will be only two types:
/* VARIABLE TYPE: 1=NUMERIC, 2=CHAR */

When I create define.xml, I notice that the length listed in not based on my datasets (ex. COREF has a length of 200 but in my dataset it is much smaller).  Are there any plans to make this data-driven?  It seems this could be a problem down the road. 

Thanks,

Maria

Hi All,

I was wondering if the config can be customized to facilitate CodeList, ValueList, etc. based on the given .xpt data for the define.xml creation? I do understand that comments and computational algorithms would have to be specified manually. As of now, with the standard config, a basic define.xml shell is outputted.

I'm assuming that the following documents would need to be modified, correct?

config-define-1.0-v1.2

• config-define-1.0.xml
• schematron --> define-1.0.xsl

Thank you in advance!

P.S.

This is one of those "we have to be able to do things in different ways because we're a CRO" questions.

Hi,

It is understood that within the define.xml the MedDRA version is indicated, in which, OpenCDISC will validate against (if the user has a licensed MedDRA dictionary present). Additionally, it is understood that MedDRA parameters would reside within a .csv, which would be identified as AEDECOD.csv. However, as a services company, we would like to utilize multiple versions of MedDRA by using a single source (i.e. AEDECOD.csv). Therefore, here are a couple questions in regards to MedDRA validation: