Define.xml

Hi,

PARAMCD 'BESTRESP' is included in two ADaM datasets (ADRS and ADIRS), while PARAMCD 'CRHRESP' is only included in ADRS data. In the VLM section of the define file, the PARAMCD value of BESTRESP is repeated twice. Would you please address this issue? The define file was generated from an ADaM specs in excel file uploaded to P21E. 

The corresponding section of the define file is pasted below. Thanks for your help.

Hi To Everyone!
I need some support, couldn't find any specification with notices how I need to filling in new columns, founded only paper list from 2018 year, from which some of variables was updated.
For example column "Assigned values" or "Source" at Variables sheet?

Please tell me the link or smth for this topic.

Best regards,
Andrei
 

I have recently noticed that when generating a ADaM Define spec the WhereClauses sheet is no longer there. Also when filling out the ValueLevel sheet I can no longer get any VLM on the Define XML. 

Hi,

I want to add SDTM version information to MetaDataVersion OID in define.xml.

For example, I want to add a bold description below: I edited define.xml via wordpad, but, after converting to data spec and converting back to define.xml using pinnacle 21, the SDTM version information I added is omitted.

With the community version 4.0 came the support of define.xml version 2.1. Thank you for the great effort on this very needed feature.

Hi all,

I have a few studies that are super old, and we use our very first version of the specs, and generate define.xml version 1.0. I'm trying to validate the define.xml using Pinnacle 21, but the errors and rejects I am seeing I have never seen while using our other validator. Things like: Missing required 'Role' value for 'ItemRef', and Missing Rank value. Does Pinnacle 21 validate Define version 1.0, or do I need to upversion to version 2.0 in order to successfully use Pinnacle 21 validator? Thanks in advance!

Hi everyone,

I generated a Define.xml based on a specification sheet in excel with the P21 Validator. Then, I validated SDTM datasets with the Define.xml. The P21 report has several findings about values not defined in the codelist. In fact, those values are in my specification sheet but they are not present in the code of the define.xml. I then assume that something went wrong when my excel file was read-in by the P21 tool to generate the define.xml.

Any idea how I could solve this issue?

Many thanks

Hi everyone,

I generated a define.xml with P21 then I tried to validated but the report is partly in Chinese. I selected FDA2010.1 as engine and ADAMig 1.1 (FDA).
In the report, I see that the configuration is Define.xml (NMPA).

How can I have the report in English?

Thank you

In SDTM define.xml, if multiple decoded values(display values) exist, how to generate codelist in define.xml?

Thank you for your help.

The EDC being used collects --REASND at the event, form, or item level (Intentionally Left Blank and ILB REason are properties of event, form, and item EDC levels). The field is present in EDC extracts, but it is not represented on the rendered CRF. It is standard to annotate the CRF with --STAT=NOT DONE when --TESTCD=--ALL, but what about annotating --REASND if not present on the rendered CRF page?