Is DD0086 removed?

r Robert

on August 12, 2021

DD0086 is said that "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."

However, I can't find it in the latest check rule. May I confirm that if it is ok to exceed the 1000 character for FDA submission?

Forums: Define.xml

Sergiy

on August 19, 2021

P21

Hi Robert, It's correct…

Hi Robert,

It's correct. DD0086 rule was removed. It's OK! to exceed 1000-charcters limit in attributes of define.xml.

However, it may be not good practice to have too much details in define.xml. Sometimes, a reference to external documents with more human-friendly format may be a better option.

Kind Regards,
Sergiy