# Define.xml Validation

**URL:** <https://forum.certara.com/t/define-xml-validation/1002>\
**Category:** Define.xml\
**Created:** [September 21, 2016, 4:08pm UTC](https://forum.certara.com/t/define-xml-validation/1002 "2016-09-21T16:08:32Z")\
**Posts on this page:** 5\
**Page:** 1

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**Author:** ![Dmitry.Kolosov](https://avatars.discourse-cdn.com/v4/letter/d/4da419/32.png) [@Dmitry.Kolosov](https://forum.certara.com/u/Dmitry.Kolosov)\
**Post date:** [September 26, 2016, 12:00pm UTC](https://forum.certara.com/t/define-xml-validation/1002/1 "2016-09-26T12:00:12Z")

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As I know there are no separate rules from FDA for the Define.xml (nor from PMDA) and I do not think there will be any because there is a specification for this file format and it should be followed. FDA anticipates that Define.xml will be validated using Pinnacle 21 (OpenCDISC), as noted on this [page.](http://www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/ucm209137.htm)

I think the reason there is a different configuration for PMDA is because some of the rules implemented by P21 are applicable for FDA only, for example a rule about 1000 character limitation which is not published by FDA as a rule, but according to P21 is FDA-specific, I would even say FDA-software specific.

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**Author:** ![XML4Pharma](https://avatars.discourse-cdn.com/v4/letter/x/b2d939/32.png) [@XML4Pharma](https://forum.certara.com/u/XML4Pharma)\
**Post date:** [September 26, 2016, 5:23pm UTC](https://forum.certara.com/t/define-xml-validation/1002/2 "2016-09-26T17:23:28Z")

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The define.xml is “the sponsor’s truth”. It is YOUR information to the FDA about the content of your submission. As submissions vary enormously, there should essentially not be any rules beyond what is in the define.xml specification (see the “Validation white paper” on the CDISC website: [http://www.cdisc.org/standards/foundational/define-xml](http://www.cdisc.org/standards/foundational/define-xml)). The only “FDA-specific rule”, unfortunately never made public by the FDA, is the “1000 character rule” that Dmitry already mentioned, and is also discussed at: [DD0086: Maximum length of 1000 characters for data attributes | Pinnacle 21](https://www.pinnacle21.net/forum/dd0086-maximum-length-1000-characters-data-attributes)

It is argued that this rule is due to the Janus data warehouse. If this is true, I must conclude (as an IT professor) that the latter is badly designed.

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**Author:** ![GMcDevitt](https://avatars.discourse-cdn.com/v4/letter/g/bb73d2/32.png) [@GMcDevitt](https://forum.certara.com/u/GMcDevitt)\
**Post date:** [October 3, 2016, 1:31pm UTC](https://forum.certara.com/t/define-xml-validation/1002/3 "2016-10-03T13:31:18Z")

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Another reason for the PMDA rules is that PMDA introduced a severity of **Reject** for certain rules where the FDA considers those rules **Error** s.

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**Author:** ![lexjansen](https://avatars.discourse-cdn.com/v4/letter/l/cc9497/32.png) [@lexjansen](https://forum.certara.com/u/lexjansen)\
**Post date:** [October 6, 2016, 11:39pm UTC](https://forum.certara.com/t/define-xml-validation/1002/4 "2016-10-06T23:39:29Z")

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@Gerard: That is not about different rules, but about the impact of breaking a rule.

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**Author:** ![swathi44](https://avatars.discourse-cdn.com/v4/letter/s/eada6e/32.png) [@swathi44](https://forum.certara.com/u/swathi44)\
**Post date:** [September 21, 2016, 4:08pm UTC](https://forum.certara.com/t/define-xml-validation/1002/5 "2016-09-21T16:08:32Z")

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Does FDA have separate validation rules to check the compliance of Define.xml like PMDA?