Define.xml

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:

Hi,

I created a Define.xml using an OpenCDISC Validator. If there are any new domains like SG(Surgery),ML(Meals) etc. which are not in SDTMIG 3.1.2 and OpenCDISC's config file(config 3.1.2.xml) then how OpenCDISC Validator will classify them as Events or Interventions or Findings or Observations etc...

Thank You,

Ashok

Hi,

I created Define.xml through OpenCDISC Validator. To get the values of RoleCodeList(Identifier,Toic,Grouping Qualifier etc.) in the define.xml should i include it in the Codelist in .xls format given by OpenCDISC which will be imported into OpenCDISC Validator??? I included and tried again but RoleCodeList is not getting populated.

Please help me with this issue.

Thanks,

Ashok

Hi,

I generated Define.xml through Open CDISC Validator by importing the files of all datasets in .xpt format. But it is not generating the values of the column KEYS in the table 'Datasets for Study define_xml(SDTM 3.1.2)' and ORIGIN,COMMENT columns in all the datasets which are being created(DM,DS,AE,.....)

Please give a solution asap.

Thanks in advance.