Define.xml

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.

In pinnacle21, I don't see this (AD), either in define.pdf, anyone has idea about this?

Many thanks

Hello,

I'm using Pinnacle 21 Enterprise to create Define.XML by uploading Excel Spec.  However, after I uploaded acrf.pdf, it did not automatically populate the page number for variables where Origin=CRF.  Any advice why this might be happening and is there anything I could try to fix this?  Thanks.

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: