Define.xml Validation

As I know there are no…

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.

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.

Define.xml FDA rules

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). 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: 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.

Another reason for the PMDA…

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

Rules

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