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?

Hi,

Validating the same Define-XML with the same settings, same SDTM CT version (2020-12-18), but with only the Data Standard differently (SDTM-IG 3.2 (FDA) versus (SDTM-IG 3.3 (FDA)) gives me different results.

  Settings Define-XML validation based on Data Standard SDTM-IG 3.3 (FDA):

Can Pinnacle 21 V3.1.2 validate define xml v2.1 ? 

Define.xml is too slow to open in IE and also slow when clicking the links within the define.  Sometimes, the define opens or the links go right away and other times it hangs for over a minute or so before it goes to the desired part.  Should there be specific settings for the internet browser to reduce the lag?