DD0003 error when running on PMDA data package

Sergiy

on October 11, 2019

P21

This is an old bug in PMDA validation

Hi Renee, 

This is an old bug in PMDA validation which is fixed a while ago. However, PMDA is still using old engine 1511.x (as of November, 2015).

There is a special element 'MetaDataVersion' in Define-XML standard. Its Description attribute is optional. However, when a value of this attribute is missing, then engine PMDA 1511.x generates false-positive Reject message DD0003.

Expected define.xml code with populated Description (code from a sample file in CDISC Define-XML 2.0 standard documentation):    

<MetaDataVersion OID="MDV.CDISC01.SDTMIG.3.1.2.SDTM.1.2"
        Name="Study CDISC01, Data Definitions"
        Description="Study CDISC01, Data Definitions"
        def:DefineVersion="2.0.0"
        def:StandardName="SDTM-IG"
        def:StandardVersion="3.1.2">

Example of define.xml code with missing Description which will results in DD0003 message when using PMDA 1511.x engine:    

<MetaDataVersion OID="MDV.CDISC01.SDTMIG.3.1.2.SDTM.1.2"
        Name="Study CDISC01, Data Definitions"
        Description=""
        def:DefineVersion="2.0.0"
        def:StandardName="SDTM-IG"
        def:StandardVersion="3.1.2">

 

You have two options to handle this issue

1. Document it is as known false-positive message in engine PMDA 1511.x
2. Populate Description attribute. One simple solution is to create excel specs using "Import Define.xml" functionality and then generate Define from this specs. The system will re-use a value of StudyDescription element for Description attribute in MetaDataVersion element.

Sorry for inconvenience.

Kind Regards, 

Sergiy

DD0003 error when running on PMDA data package

Just like the earlier post about the prime sign (https://www.pinnacle21.com/forum/validating-values-containing-prime-signs) I am suprised that people ask "what is 'MetaDataVersion'". It testifies that many people even do not take the effort to have a look at the contents of a define.xml file. Just open it using e.g. "NotePad++" and a new world will open up for you. Taking a CDISC Define-XML course will bring you up to a high level ...

To extend Sergiy's answer: MetaDataVersion is about "versions of metadata". In a submission define.xml you will only have the latest version of your metadata descriptions. But in the course of the development, you may of course have different ones. "MetaDataVersion" comes from the ODM standard, where it has exactly the same goal: to allow to describe different versions of a study design. Populating the "Description" attribute has however never been mandatory by the Define-XML v.2.0 specification.

As Sergiy already stated, this should be regarded as a bug in the software. I am bit surprised it was not corrected in the latest version. A quick "work around" is already provided by Sergiy.

Sergiy

on October 12, 2019

P21

Hi Jozef, As I've already…

Hi Jozef, 

As I've already said, the bug was fixed a while ago. The issue is that PMDA is still using an engine version released in 2015.

BTW, PMDA was the first user who reported a bug in DD0003 due to incorrectly required Description attribute.

Also, I do not see any reason to blame regular users for not being proficient with direct XML coding. They focus on other important things. Our goal is to support and help them with technical issues. 

Kind Regards, 

Sergiy

MetaDataVersion

Thanks Sergiy!

I agree that we disagree :-)