Define.xml

Hi,

Validating the same Define-XML with the same settings, same SDTM CT version (2020-12-18), but with only the Data Standard differently (SDTM-IG 3.2 (FDA) versus (SDTM-IG 3.3 (FDA)) gives me different results.

  Settings Define-XML validation based on Data Standard SDTM-IG 3.3 (FDA):

Can Pinnacle 21 V3.1.2 validate define xml v2.1 ? 

Define.xml is too slow to open in IE and also slow when clicking the links within the define.  Sometimes, the define opens or the links go right away and other times it hangs for over a minute or so before it goes to the desired part.  Should there be specific settings for the internet browser to reduce the lag?

HI,

I am validating a define.xml generated by P21 community and it generates the OD0021 Invalid Language value. The define was created using specs(from old define) generated by P21 community.

This  is an example value for the issue is below:

5003, <TranslatedText xml:lang="">PD24SHC</TranslatedText>

Can you please help with debugging the issue.

Thanks,

I have a question about how to set the length of integer or float variables in Define.xml.

If the variable has the values like 2.1, 3, 4, 11.3, 12.2, 99 then I guess, the length will be set as '3' with significant digit 1 and its format is float.

However, if some minus values are included in this variable, like -1.1, -2.1, -10.0, how can I set the length of the variable?

Should the minus sign(-) be taken into account to calculate the length?

DD0086 is said that "Invalid length of attributes in Define.xml - FDA's Clinical Trial Repository (CTR) software currently has a maximum length of 1000 characters for data attributes in Define.xml."

However, I can't find it in the latest check rule. May I confirm that if it is ok to exceed the 1000 character for FDA submission?

Hi, All:

I am trying to create ADaM Define-XML through P21 Community v3.1.2 (not Enterprise), and I have one question.

Extracted metadata from SAS XPT datasets, and I created Define-XML excel specs.

I think, after entering required info & uploading the specs to P21, I can generate Define-XML I want.

It's helpful for me, if there is manual about how to complete the excel specs (or "What info should I enter to each cell & Where should I enter?").

Could you please tell me where manual or reference doc is.

In order to specify NCI codelist which is used mulitiple ADaM datasets, there is a rule for the case described below?

For example, NCI Codelist "Unit (Codelist code : C71620)" is used for ADCM, ADLB and ADEX for describing CM dose unit, LB test result unit and EX dose unit in each datasets.
And each values of unit included in each ADaM are different according to the datasets. (ex. ADCM : mg / ADEX : mg/kg, mg/m2 / ADLB : %, AUC etc.) 

Hello,

I am using Pinnacle version 3.1.0 to validate (and first of all to generate) my define.xml file and this error occurred:

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).

I tried everything I could possibly find to solve this problem - I checked the hidden characters, I checked blanks at the beginning, I checked all the namespaces: 

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

I am using the community version.  The part that I am  talking about is the Define.xml tab > Create Spec. The configuration I am using is ADaM-IG 1.1.

When I hit "Create" button, I get a blank Excel Specification define xml template, and none of the variable metadata seems to have extracted from the .xpt files.

Can someone help me get Pinnacle to extract the metadata from my XPORT file? I'd be happy to provide any information that can help you help me!