Define.xml

Hi All,

We're in the process of validating a data package (incl. define.xml) and the warning DD0148 is being triggered. Interestingly, I couldn't find any additional information about this rule in the set of validation rules (Define-XML Validation Rules | Pinnacle 21) but that's not my main concern.

Dear,

I created one define spec from define.xml in Pinnacle 21 community, and there are two records for APQS domain in ValueLevel tab, as shown below.

Hello. This is related to style sheets for Define.xml 2.0 ADaM. I'm having trouble locating a style sheet that does everything I want it to. Thought I would reach out to the community before I try to change ours. What I am finding is there is a group of style sheets that works with all browsers like Chrome, Edge, IE. However, the stylesheets I've found do not allow for links to the adam reviewer's guide to go directly to a specific page. They all go to page one.

Hi,

It seems that P21 has wrong labels in its model SDTMIG 3.3:

- ECOCCUR: expects 'Occurrence Indicator' while SDTMIG has 'Occurrence' (source: SDTMIG 3.3 section 6.1.3.2)

- TSVAL1, 2, 3...: expects 'Parameter Value 1, 2 ...' while SDTMIG has 'Parameter Value' (source: SDTMIG 3.3 section 4.5.3.2)

Could this be corrected? Or do I miss something?

Thank you.

Hi all,

While validating the adam define.xml, the issue DD0107 - "Origin for RDOMAIN variable is not set to Assigned" appeared for the ADCO (Comments)  analysis dataset. 

In the ADCO analysis dataset, the origin of the ADCO.RDOMAIN is set to Predecessor because the values are copied straight out of the variable SDTM.CO.RDOMAIN.

Dear all,

When generating define.xml and using P21 Community validator, we found a quite interesting issue, DD0112 'Missing MedDRA definition':

There was information of MedDRA with a name and version in both variable's CT and External Dictionaries parts, however this issue still came out without more information about why and how this issue occurred or resolved. 

I have a type of CRF Page number like 1-8 20 with both PageRefs and PageFirst/PageLast, is there any proper way in define specification to make the link available for all the numbers?

Hi,

I'm attempting to create an SDTM Define (using 2.1 standards) and I'm getting the following rule triggering for a number of my codelists:

DD0132: 'Invalid use of def:ExtendedValue attribute'

I'm not sure where its getting the idea that I've extended these codelists because I don't think I have - as an example, it's triggering on the codelist 'Age Unit', on the term 'YEARS' (and this is the only term used). Is there something I could be doing by accident that is causing this error to appear?

Many thanks

AppId: us-east-1:afa1e0dc-841c-42d9-babf-764e9c6589d8
PinnacleId: xinhua.zhou@immunogen.com
Application Version: 4.0.2
Platform: win32
Architecture: ia32
Release: 10.0.19045
Free Memory: 6401458176
Total Memory: 17013338112
CPUs: 8
RDP: false
Citrix: false
ErrorId: e18488b435720efb97c5db29319e600c

Is this the issue of P21 bug or define.xml syntax issue?