d Dmitry


Dear Pinnacle team, great thanks for the release of the Pinnalce 21 2.1.  It looks like there are many important and good check in the new version. Could you please help to find a reference document/page for rule DD0086 from FDA? After googling for a while I could not find any reference.

Forums: Define.xml

g Gerard
on December 9, 2015

Hi Dimitry,

The FDA has not published the define.xml rules yet, so we probably added this check prematurely. We will check back with the FDA on the merits of this check and will get back to you.

Thanks for bringing this up,


g Gopalakrishna
on July 5, 2016

Dear Team,

There may be chance for having >1000 characters for complex algorithms/comments/ARM section. In this case, do we need to restrict to maximum 1000 characters and make meaningful OR leave as it is without considering this issue.

l Lex
on July 5, 2016

I wonder how accessible these large blobs of text in a Define-XML file are for reviewers. It may be better to reference a document, where you have full control over layout. Define-XML v2 has excellent capabilities of linking directly to a  page or named destination.

Lex Jansen
Define-XML dev team

j Jozef
on July 6, 2016

There is no such rule. The only reason I can think of that someone invented this is that it is assumed that the define-XML contents are or will be stored in a relational database using a VARCHAR(1000). However, XML documents should better not be disassembled but stored entirely, e.g. in a native XML database, or in a hybrid database e.g. using the XMLType (as in Oracle) or similar.
But as Lex already stated, if these characters contain pure text, the better way is to put the text in a separate document and reference it from within the define.xml.
In our SDTM-ETL software, we store all the mapping scripts within the define.xml. Usually they are less than 1000 characters, but not always. Our users however usually remove the scripts from the define.xml when going in the submission phase.

g Gopalakrishna
on July 6, 2016

Thanks Lex.


Reference document means data guide or Supplemental document?

l Lex
on July 6, 2016

Hi Gopalakrishnan, 

Yes, that is what I meant.

g Gopalakrishna
on July 7, 2016

>1000 characters comment may affect readability. While running report it throws an error [Invalid length of attributes in Define.xml]. But it could be Warning, not error. please confirm.

j Jozef
on July 7, 2016

Hi Gopalakrishnan R,

There is no such rule, so there should be no warning either. There just should be nothing reported. It is up to the CDISC define.xml team to decide what the rules are. Only the FDA can add some, but then these should be documented. This is not the case at all here.

Once again: there is no such rule!

s Sergiy
on July 7, 2016

Hi Gopalakrishna, 

This check was asked to be added by FDA as blocking rule for uploading data into their new CTR (Janus).

Recently the rule specifications were adjusted to be limited to only some specific attributes as Codelist Decode TranslatedText. New  version of validation for define.xml will be available soon.

Kind Regards,



j Jozef
on July 7, 2016

Thank you Sergiy!

Can you please point us to the publication or document of the FDA where this rule is given? I could't find it in the "Study Data Technical Conformance Guide", nor anywhere else on the FDA website.
I still assume that even the FDA is not allowed to have you implement rules that are not public isn't it?

Many thanks in advance,


Want a demo?

Let’s Talk.

We're eager to share and ready to listen.

Cookie Policy

Pinnacle 21 uses cookies to make our site easier for you to use. By continuing to use this website, you agree to our use of cookies. For more info visit our Privacy Policy.