DD0086 in Define.xml (PMDA) should not be included since it is a FDA rule.

Pinnacle 21 Support Define.xml
1

Thanks Ebi. DD0086 will be removed from Define.xml (PMDA) in the next patch release (v2.1.1).

2

The rule DD0086 “Invalid length of attributes in Define.xml - FDA’s Clinical Trial Repository (CTR) software currently has a maximum length of 1000 characters for data attributes in Define.xml.” is included in the Define.xml (PMDA) config xml, but the rule is for FDA and is not included in the PMDA guidance (http://www.pmda.go.jp/files/000208341.zip).

The rule should be removed from the PMDA config.

Thank you,

-Ebi