When creating relationships, a file reference must be selected from a previous sequence to modify. By default, available documents will be available in dropdown list from the current eCTD section throughout the application. The dropdown box will display information about each file reference, including its title, state, and sequence number. This can be done in two views: Origin and Life Cycle.
Relationships via Origin View
Relationships via Life Cycle View
Adding a Relationship in Different eCTD Sections
All eCTD operators can be applied to a document in the Origin view through the Relationships tab. If this tab is not showing, navigate to View > Tabs. Select the Relationships option and it will appear in the Details pane.
If the operator is added to the modifying reference, or the one doing action, the relationship will be added to the File References that I Replace, Append to, Link to, Delete, or Reactivate section.
When the selected file reference is the reference being modified, or previously submitted file, the relationship will be added from the File References that Replace, Append to, Link to, Delete, or Reactivate me.
Note: The Delete operator can ONLY be added in Origin view. Additional information on the Delete operator can be found in “The Delete Operator” section.
In the example below:
• A document in sequence 0003 (3.2.S.2.1. Manufacturer(s)) is replacing a document in the same section, but from sequence 0002.
• The new document is selected and the relationship created to replace the earlier document.
• The File dropdown displays all file references in section 3.2.S.2.1, from all sequences.
The Manufacturer(s) document was selected.
In eCTD format, only documents with a state of Current, or New can be replaced, and a selected reference can only have a relationship for one document. If a document has already had a lifecycle operator associated with it and another relationship is added, PUBLISH will throw an error message.
Relationships via Life Cycle View
In Life Cycle view, the Replace and Append lifecycle operators can also be added via drag and drop.
Open the application in Life Cycle view.
Set an Active Sequence for PUBLISH to write to.
• Because multiple sequences can be in progress at the same time, setting the active sequence allows PUBLISH to place the documents into the correct sequence.
• Only sequences with a state of In Progress will show up in the list.
Find the file reference to modify.
Drag and drop the new document on top of the existing document.
• Choose the correct relationship from the popup.
The operators will be added to the application.
Adding a Relationship in Different eCTD Sections
Normally, a relationship relates to a file reference contained in the same eCTD section. However, if a document relates to a reference in a different eCTD section, click the small button next to the Section field (
) to display the TOC to choose the other section, as shown in the following image. Once the correct section is selected, the File dropdown will repopulate with file references from that section. This must be done in Origin view.
