Define.xml

Hi,

Our ADaM define.xml includes the Analysis Result Metadata (ARM). We run Pinnacle 21 community version 2.2.0 to validate define.xml itself, and the Pinnacle 21 report is clean with no issues. However, I am wondering why the Pinnacle 21 report is empty, since DD0000 “ARM metadata included” should be presented in the issue summary of P21 report.

DD0000 is present in the rules tab:

Hi all

At the dataset level, there is the variable called STRUCTURE, does anyone know if there is a max length for this field ? Also is it permitted to change this text, I know the KEYS can be adjust per the SDTMIG but there is no guidance on the STRUCTURE.

Best

Colm

I would like to confirm assigning the CRF pages for IE domain with amendments and Cohort groups. As IE domain has 3 groups and 4 amendments, which is best practice to provide CRF page links? Is to assign the first occurrence of original IE or with all amendments?

Thanks

Arjun

Hi

I use Pinnacle 21 to create Define.XML (SDTM-IG version 3.2) and I am faced with a problem that I did not have before.

In the column « Origin » of the sheet « Variables » of the Excel Metadata, I refer to « CRF » (« CRF » in the column « ID », « Annotated CRF » in the column « Title » and « blankcrf.pdf » in the column « Href » of the sheet « Documents ») and I write the corresponding pages in the column « Pages » of the sheet « Variables » too.

Hi,

I got the following error :

"QRS Method, VISUAL ANALOG SCALE (100 MM) DD0029 Required attribute def:ExtendedValue is missing or empty."

Hi Team,

While our team was generating Define.xml, validator showed up some error message regarding Associated Person domain. The message was "Name/Domain/SASDatasetName mismatch", indicating that ItemGroupDef, Domain, SASDatasetName, Name are presenting "APDM", "AP", "APDM", "APDM", respectively. (I've attached the snapshot below)

I was wondering how should we handle this error message or how should we explain it in cSDRG? Many thanks for the time and help.

Regards,
Cheng Chang
 

Dear Team!

We are getting DD0039 errors  in 2 scenario’s.

#1. EPOCH, was the only timing variable kept in CO, which cannot be dropped due to dependencies in data .

#2. EVAL in AE, differentiates AE reported by Investigator or adj Committee . Else data has duplicate records.

Reason why, we had to keep them in SDTM. 

Since these are not SDTM variables as per IG,  and also not in configuration file from pinnacle, we kept them at the end.. after all variables.

Hi Team!

We had CT2003 error for a Lab test EGFR. And in define, We see error for DD0032 . EGFR was shown as an extensible codelist, with no NCI code .

Given the scnerio, that fixing CT2003 is not feasible owing to complex dependencies, is there any possibility of fixing this error in define.xml?

Thank you

Jyothi

I can only display define.xml with stylesheet define2-0-0.xsl in Internet Explorer, and cannot show in Microsoft Edge, which is upgraded version and replace IE. Do you have solution (provide new stylesheet)?

Also, how to display define.xml in Google Chrome, Firefox or other browsers?

Jimmy Zhao

"exception":"CLI.3.12::Failed core process.::Failed local validation process

I'm getting the above error message while executing for check ADaM/ SDTM define.xml only for the 1903.1 and 1810.3. It is working fine for 1511.6 engine. Can you please provide a solution for this or what might be the reason for this error?