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changes.mady.by.user Lorraine Sobson

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changes.mady.by.user Lex Jansen

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AttributeSchema Datatype or EnumerationUsageAllowable ValuesDefinitionBusiness Rule(s)Description
IDRequired

The leaf ID is based on the XML xs:ID datatype, which is a Non-Colonized Name; therefore, ID attributes must start with either a letter or underscore (_), and may contain only letters, digits, underscores, hyphens and periods.

Required
  • Unique ID for the leaf. See Section 2.11, NullFlavor Information, for OID considerations.
  • Business Rule: leaf ID attributes must be unique within the Define-XML document (i.e., there can be no 2 leaf elements with the same ID attribute).

xlink:hrefRequired

xsd:anyURI

Required
  • URL that can be used to identify the location of a document or dataset file relative to the folder containing the Define-XML file. If the file is not located in the Define-XML folder, a relative file path should be included.
  • Business Rule: For regulatory submissions to the FDA, the locations specified have to conform to locations allowed in the eCTD, in the Technical Conformance Guide for the relevant regulatory authority and the study data specifications.