Section (Node) Extensions are a provision for extending the CTD Table of Contents to a lower level than defined by the regulatory authorities. They will be shown as extra headings in the CTD Table of Contents.
In general, Section (Node) Extensions should be added only at the lowest level of the TOC. For example, you can extend the Section 2.3.R Regional Information but not the 2.3 Quality Overall Summary section since the latter is not the lowest element defined in the eCTD TOC.
Note: In Europe and Canada, Section (Node) Extensions are recommended for additional granularity (Ref. 7) supplies a number of guidelines on the use of Section (Node) Extensions for EMEA sequences). In the US, the use of Section (Node) Extensions is strongly discouraged and should be avoided unless agreed in advance with the FDA.
Note: Publish’s repeatable section capability to organize studies can also be used for EMEA and Health Canada. Publish will automatically generate compliant Section (Node) Extensions when sequences are published
See the following sections for additional information:
Add a Section or Node Extension
To add a node extension, select an existing section (either a standard TOC section or another node extension) in Origin view. Select New > Section (Node) Extension from the Manage menu
If a section is not at the lowest level, the option to add a Node Extension will not appear in the context menu.
A title must be supplied for newly created extension, and it cannot duplicate the name of any other node extension that already exists in the same section.
Modify a Section or Node Extension
To modify the title of a Section (Node) Extension, display the Section (Node) Extension in the Details or Inventory grid (by choosing it or a parent section in the tree) and modify the title by clicking in the title field and typing the new title.
Note: Changing a node extension’s title will only affect in-process sequences. If you have already finalized or submitted a sequence using the original title and then change it, reviewers will see multiple sections instead of a single corrected section. For example, if, in Sequence 0000, you used a Section (Node) Extension title of “Study 2007- 0012” and, in Sequence 0000, you correct the title to “Study 2007-0013”, reviewers will see documents spread across two sets of sections (folders). Generally, this is not advisable.
Remove a Section (Node) Extension
A Section (Node) Extension may be removed only if it contains no content (file references or Section (Node) Extensions) for any sequence in the current regulatory activity. To remove a Section (Node) Extension, choose the Section (Node) Extension in the tree and select Remove from the Manage or context menu.