Define.xml

Hi, my first forum entry so please be kind.

I'm using P21 V2.1.3 to create SDTM and ADaM DEFINES and overall have found that it is a great package.

I woudl like to improve the 'look' of my defein in two areas if possible.

1) I have several very large comments which ideally would be referenced via a link in a separate comments section rather than displaying as a regular comment.

As I'm typing I'm thinking perhaps link to a separate document but is there a simpler way?

Hi,

The valid origin values for SEND are not as specified in the DD0073. The valid values are: COLLECTED, DERIVED, OTHER and NOT APPLICABLE as specified in the define 2.0:

http://wiki.cdisc.org/display/PUB/Define-XML+2.0+errata

Will you update the check so it does not report error for SEND define.xml?

Does FDA have separate validation rules to check the compliance of Define.xml like PMDA?

Pinnacle21 community v2.1.3 gives a warning D0059, Define.xml/CDISC dataset Description mismatch

it seems to expect the plural "Body Weights" to be the dataset name.

The SENDIG shows the BW domain name with the singular "Body Weight".

Hi,

I am using Pinnacle 21 Version 2.1.3 to create and validate define.xml. In spite of giving correct codelists values in metadata, validator is picking this error as "Unknown NCI Code" for all codelists. The error is further related to DD0034 as well. Any suggestions to remove these or is this a bug in community tool.

Thanks.

Regards,

Sachin

I downloaded the new version 2.1.3, run the validator for define.xml. I got the schematron file does not exist exception, see below on my 1st run.

I copied the folder from 2.0.1 version, since that is the version it works and has this folder. Run the command again.

Now I got different exception. see below on my 2nd run.

Please help, Is it implemented to run the define validator in command line mode or not?

thanks,

1st Run:

Hi,

I have mentioned all the required fields in value level metadata in the excel spreadsheet which creates define.xml. But for all VLM getting this error which is FDA mandatory variable. Any idea to overcome this.

Sachin

Hi,

Using the latest version 2.1.2, I get an D0060 "Define.xml/CDISC variable Label mismatch" for variables Sex and Race with label Sex and Race. See below the error inthe report:

Variable, StandardLabel, DefineLabel IT.ADSL.SEX, Sex, Sex 

I am wondering if the validator is incorrectly flagging this as a problem?

Thanks,
Rob

Hi Team,

I am using Pinnacle 21 Community tool to generate the Define.xml , When I try to open the Define.xml file it opens with the Word and not in the webbrowser. Can you kindly guide on this .

Thanks,

Priyanka

When validating a define.xml file for SEND data, I am getting the following error:

Define.xml/CDISC dataset Description mismatch: - Macroscopic Findings, IG.MA, Macroscopic Findingss

I found that the SEND 3.0 (FDA).xml file (located here: PINNACLE\components\config\) comes with this misspelling (Findingss instead of Findings).

I am using Pinnacle21 Community Version 2.1.2.

Thank you!

Jose Orellana