Troubleshooting and Problems

DD0068: Invalid use of Length error is received when validating a define.xml version 1.0 file that uses ODM 1.2

datetime, date and other ISO8601 format variables should not use Length attribute according ODM standard.

Define-XML 2.0 uses ODM Version 1.3.2 (according to the recently-published errata page previously referenced).  That ODM version states: “The Length attribute is required when DataType is text or string, optional when DataType is integer or float, and should not be given for the other datatypes.”

Pinnacle 21 Validator v2.1.1 cannot execute validation on define.xml - validation works fine on v2.0.2.

I can manually correct the file to get the validation to work on v2.1.1, but I can't find that there is any specific requirement in the define-xml standard that requires the particular syntax that

The problem seems due to continuous XML text between stylesheet reference and ODM element. To run validation, some break between sections is necessary. For example, adding <carriage return><new line>

Original XML text:

…

Pinnacle 21 Validator v2.1.1 cannot execute validation on define.xml - validation works fine on v2.0.2.

I can manually correct the file to get the validation to work on v2.1.1, but I can't find that there is any specific requirement in the define-xml standard that requires the particular syntax that

The problem seems due to continuous XML text between stylesheet reference and ODM element. To run validation, some break between sections is necessary. For example, adding <carriage return><new line>

Original XML text:

…

Could you please confirm if CLI is now fully functional... if not could you please confirm under what situations it doesn't work?  e.g.  ADaM validation, Define validation, etc

Disregard this.  My own error.  It can be deleted by forum admin.

I get this incorrect warning with Pinnacle21 Community 2.1.1 Validator for my EX domain.  I've confirmed the order of the variables matches the SEND IG 3.0.

VARIABLE, DATASET
EXMETHOD, EX
SD1079
FDAN035
Variable is in wrong order within domain
MetadataWarning

When replying to a message and using "Preview", instead of the message word "Array" is shown in the editor box. Tried in FireFox ESR 38 and Chrome 47.

Hi

I am using Open CDSIC validator 1.5.

I am getting the following notice 'D:\OpenCDISC\opencdisc-validator\config/data/CDISC/SDTM/2015-12-18/SDTM Terminology.txt is missing or lacks necessary variables and cannot be used for this cross-dataset validation'

Please give me the solution.

We are getting these errors in the P21 report for a study.  The issue is “Pharmacological Class” for Levofloxacin.  We used “Fluoroquinolones” with a code of N0000011190.  However, P21 says it is not found in NDF-RT.

Looking in the configuration file supplied with v 2.1.1 I cannot find this reference in there. But it is present when I download the entire text file. I know that I can replace with an updated txt file but will this same error occur with the FDA Enterprise version when we submit?

Thanks

Dave Borbas 

I was having trouble with this check, but have been able to clear most of the issues now. The TI and IE are giving me messages, but I understand why and can figure out the best fix. However, when I ran the SDTM example through Pinnacle 21 this check came up for the TS domain. Other checks come up too, I think the example define.xml should be clean for users.