| Study Patient Information
|
|
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.
|
| 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.
|
| 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.
|