Define.xml

When the same whereclause is used multiple rows in ValueLevel sheet, the text "Derived" is displayed multiple times in each of the metadata records in Origin/Source/Method/Comment column in define.xml. Please see the attached screenshots. Thanks, Sophia

If i would like to add a link to a document in define.xml, how should i do in Excel ADaM spec? I try to add a documentation name in document column in comments tab and link to document tab. It didn't work. 

Thanks, 

Sophia 

Hi,

We do NOT use P21 to create our Define.XML outputs however we do use P21 to validate our Define.XML outputs. Currently we are running version 3.0.0 and I have noticed the following message and I am not sure why it is appearing:

DD0102 - Invalid Annotated CRF document name - Guidance provided by regulatory agencies (FDA and PMDA) states that the Annotated CRF should be provided as a PDF with the file name 'acrf.pdf'.

Dear Team,

Could you please explain the reason DD0031 fires for TSVALNF variable when I validate SDTM define.xml? As per the error Pinnacle21 v3.0.0 expects NCI code C117459 for Null Flavor codelist, but Null Flavor codelist does not exist in CDISC SDTM controlled terminology, and C117459 is the code of TSVALNF variable itself as per the NCI Term Browser. 
Why this codelist was added into the CT version Pinnacle21 uses for validation and how people who create define.xml should know of this? 

Thanks,

Igor 

Hi Team,

Is there a way to add second, third etc VLM within domain using Pinnacle21 define.xml genarator?  It looks like ID column of the WhereClause tab of the spec is completely ignored by generator and instead the variable column used to generate ID within define.xml. The thing is that if I want to, e.g. , create VLM for LBORRES, where LBTESTCD EQ INR, and for LBSTRESC where LBTESTCD EQ INR, the variable column in the spec will be the same (LBTEST) for both VLMs and as a result in define.xml where clauses will be duplicated.

 

Hi Team,

When I try to complete Description column for value-level metadata of SUPP datasets, the description text does not appear in generated define.xml. It looks like corresponding /Itemdef elements are not created during define generation. Is it known issue of latest version? 

thanks,

Igor 

Hi Pinnacle Team,

Please help to clarify Pinnacle 21 error: SD0037/FDAC037 Value for LBSTRESC not found in (Laboratory Test Standard Character Result) user-defined codelist.

Numeric lab results are not part of Laboratory Test Standard Character Results codelist. In user-defined codelist, we left only alpha values as per SDTM terminology.

How do we avoid this error: do we need to include every possible numeric value in Codelist?
Or completely ignore CDISC requirement for LBSTRESC CT on Variable Level?

Hello.

I want to create define.xml using P21 metadata. When I try to get Excel Spec for ADaM using XPORT Datasets or already completed define.xml with analysis results section, I get a filled Spec but without analysis results. How should analysis results worksheet looks like in metadata created by P21 Community?

Thank you.

This is a follow-up on the issue previously published here: https://www.pinnacle21.com/forum/2018-09-28-sdtm-ct-format-not-compatible-pinnacle-community-v220

After installing the new CT versions as mentioned in the above forum, the validation for define.xml no longer works in P21 community 2.2.0 for these CT versions.

Hi everyone,

I created an small SAS program to modify a custom excel format into Pinnacle compatible one. When I try to enter the excel to create a define.xml I get the following crash error