Define.xml

Is it possible to specify links to multiple supplemental files in a single variable source/derivation, or do we need to provide value-level metadata pointing to each file separately?  We're creating Define-XML via P21C using the Excel specs template, and have tried associating all of the files with the same comment, and then referencing that comment from the variable metadata, but only the last file defined in the list is displayed in the resulting Define-XML file.  What are we doing wrong? 

In the Excel define spec of Pinnacle 21 Community v4.0.1, a column named "Assigned Value" has been added to the Variable and ValueLevel sheets.
What should be entered in this column?
Which of the Element/Attribute defined in the Define-XML v2.1 specification issued by CDISC does this correspond to?

Kind regards,

Takayuki

If import EXCEL SPEC in P21,the following ERROR is displayed.

Can you provide an EXCEL SPEC(Analysis Displays,Analysis Results sheet) for reference?

Hi, Team

Using Pinnacle21C Ver.4.0, 
I am going to create Define-spec.xlsx with ARM from Define.xml where "Selection Criteria" entered.
But, only "Selection Criteria" column in the Analysis Results sheet of Define-spec.xlsx is blank.
The columns except "Selection Criteria" is filled.
Pinnacle21C may break down？

Best regards, Sato

Can Pinnacle21 Enterprise a provide a define.xml for legacy analysis datasets (non-compliant ADaM)?

We were asked to do new ISS and ISE analysis, for a label change, on several NDA original studies from as far back as 2007.

We created ADaM-like datasets from the original raw data for this analysis.

Since this data will be submitted for the label update, we assume that a define.xml should be included.  

Hi Team,

I tried to generate define.xml version 2.1, but the "Analysis Parameter(s)", "Analysis Variable(s)" and "Data References (incl. Selection Criteria)" were blank whatever I typed in the "Variabls" and  "Selection Criteria" column in the Analysis Results sheet of define-spec.xlsx.

Can you provide some examples?

Best Regards.

Jimmy

Hi all,

I am generating the define-xml with the generator of Pinnacle for SDTM and I am submitting an Excel file as an input.

In the resulting define-xml, the variable 'MITEST' from the MI domain is not present although it is present on the Excel input file.

What I find more strange is that I ran the define with the same excel file previously, the variable was present in the define-xml.

Did you ever had this issue before?

Thanks

I'm trying to create the Excel Specification by first extracting metadata from SAS XPORT SDTM datasets. 

I am using the latest community version.  The part that I am talking about is the Define.xml tab > Create Spec. The configuration I am using is SDTM 3.3.

I put 30 datasets and only get Excel Specification with DM metadata, other datasets not in Excel Specification.

how does this happen? no error information about this situation and is there any requirements for XPT dataset and why P21 only recognize DM dataset？

Hi,

Please Clarify, DD0131 - rule expects that there is one to one match between Code list OID and Code list Name [Label] OR can we populate Common Code list Name for common variable [Example for Codelist OID=AE.DOMIN, DM.DOMAIN, CM.DOMAIN,... - can we have same Code list Name [Label] as "Domain Abbreviation" instead of "Domain Abbreviation (AE)" "Domain Abbreviation (DM)" "Domain Abbreviation (CM)",...? 

If we give same Code list Name [Label] for a set of Code list OID's then what could be the impact?

Hello,

Define xml v2.1 --> As per published sample define xml, Location Column is missing when HasNodata=Yes. But it seems, P21 validation expects the value. Attached screen shot for reference. Please provide your valuable suggestion.

Thanks.