Extension Type:Leaf Types

Extension Type Associated Attributes

Applied to

Assembly Element

 Result
Study Patient Information

— Subject Matter

— Site

 Can be applied directly to CRF and/or Subject Matter leaf elements in lieu of using the inheritance structure using the same folder type. See Study Patient Information Folder.
Extension Type Associated Attributes

Applied to

Assembly Element

 Result
EAEU Module 1 Envelope No additional Attributes

Applied to a placeholder leaf element that holds

envelope information.

 Is automatically duplicated for each new working assembly to ensure that the appropriate envelope information is available and managed by the sequence.
EAEU Leaf

— Registration File

Indicator

— Drug Registration Document Code

— Drug Registration

Document Name

— Drug Registration File Section

— Drug Registration File Code

— Drug Registration File

Name

— Document Creation

Date

— Document Validity

Date

— Business Entity Name

  • Request Response Date
  • Reason Document Number
  • Requested Drug

Registration File

Section

  • Requested Drug

Registration File

Code

  • Requested Drug

Registration

Document Code

  • Other Information
  • General

Information

Applied to each leaf

in an EAEU submission.

 Is applied to each leaf of EAEU submission to enable users to indicate additional attributes, if necessary.
Extension Type Associated Attributes

Applied to

Assembly Element

 Result
EU Module 1 Envelope No additional Attributes

Applied to a placeholder leaf element that holds

envelope information.

 Is automatically duplicated for each new working assembly to ensure that the appropriate envelope information is available and managed by the sequence.
GCC Module 1 Envelope No additional Attributes

Applied to a placeholder leaf element that holds

envelope information.

 Is automatically duplicated for each new working assembly to ensure that the appropriate envelope information is available and managed by the sequence.
Japanese Module 1 Leaf Sequence Applied to each leaf in the JP Module 1 assembly template. Creates the appropriate <property> element with the attribute name="sequencenumber" using the value of the attribute to populate the value of the <property> element in the jp-regional-index.xml file.
JO Module 1 Envelope No additional Attributes

Applied to a placeholder leaf element that holds

envelope information.

 Is automatically duplicated for each new working assembly to ensure that the appropriate envelope information is available and managed by the sequence.
Study Report Subject Matter Leafs in a Study Report. See Study Report folder.