Define.xml

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!

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.