Define.xml

Hi,

I have used Pinnacle 21 Community to create Define Spec file and filled in dataset and variables information, then used it to create Define xml file.  I am seeing DD0029, "Required attribute def:ExtendedValue is missing or empty", message from the Define xml validation.  

Good day all,

One of our team members is trying to create the Define.XML spec using p21, and was hoping to reference one of our custom config files. We placed the custom .xml files under the "custom" folder under "config", and this works well when using the validation function. However, when navigating to the create spec function under Define.XML, we cannot see any of the custom configurations in the drop down list. Is it possible to have the create Define spec function point to both the standard configs as well as the custom configs as we've done for the validation piece?

Dear P21C,

I used the latest P21C Version: 3.1.0 to validate the ADAM .xpt datasets with the define.xml. And it looks like only the .xpt datasets are validated and the define.xml is not validated(pic1). And the validaiton report ‘Dataset summary' tab also does not list the define.xml there. Is this an issue with the P21C? Thank you very much. 

Seeking some advice on the 3 columns in the title "Repeating", "Reference" in the datasets tab and "Mandatory" columns in the variables tab in the P21 spreadsheet to generate the define.xml for ADaM.

"Repeating": if set to "Yes", does it mean  the structure of the dataset should be one record per subject only, and so the key structure could be USUBJID only?

The aCRF opens when I access it through the first link available in the top left corner of the define in the side bar. But when I try to access the individual pages associated with the variables, I am not able to. Could you please let me know what am I doing wrong? Thanks

Please see the snapshots of SDTM define, variables tab of define.xlsx, how the acrf is referenced in the documents tab of define.xlsx, attached. 

After replacing my laptop and OS and reinstalling P21C, DD0001 is now detected with the validation of define.xml. (DD0001 was not detected in the previous laptop and OS environment)

DD0001: Cannot find the declaration of element 'ODM' using the namespace(s) found on the element. Confirm that 'ODM' is allowed in the Define.xml Standard and has the correct namespace(s).
 

Hello,

We recently began including a Length of "0" in our define files for variables/value level metadata that are completely blank.  During define validation, we are receiving a message saying "Invalid integer value for 'Length'" for these variables.  Is this a bug with Pinnacle, or is there a reason "0" would not be detected as an integer for the Length attribute?

Thanks,

Adam

Hi,

We have FAxx domains [FAAE, FACE, FAMH,...] in the SDTM package. While validating define xml with P21 V3.1.0 [FDA version, SDTM IG 3.2], we are getting DD0114 message. Because as per IG 3.2, FAxx domains comes under FINDINGS ABOUT CLASS.

As per DD0114 P21 rule, FAxx domains are not comes under General Observation Class. So, we are getting this message in the report.

Please suggest, shall we consider this as False-Positive for this case?

Thanks in Advance.

Screenshots attached.

What are different about the pinnacle 21 validation results for the define.xml, between on the validation to the define.xml together with xpt datasets and to only the define file?

Hi,

We are currently using Pinnacle21 Community version to create define and validation. We are able to create the define in v2.0 format. Is there a way to create define.xml in v2.1 format using Pinncle21 Community version. Please help.