Supporting Assemblies

A supporting assembly is an assembly that is part of an application, but is not part of an eCTD life cycle for that application.

You can create as many supporting assemblies as you need. Circumstances when you might want to use supporting assemblies could include: making paper copies for CTD reviewers, or creating study reports.

For example, if you need to create a CTD reviewer copy in addition to the eCTD sequences, you can copy the publishing view of the eCTD sequence to a supporting assembly, and then publish to paper from the supporting assembly.

Ennov InSight Publisher 7.3 Supporting Assemblies

Create a Supporting Sequence Assembly

Use this procedure to create a supporting sequence assembly. You can import an assembly, add volumes, files, and folders.

To create a supporting sequence assembly:

  1. Select the new assembly and click Assembly. Two options are available for the new assembly:
    Option Description
    Create Working Assembly Use this option to create a life cycle sequence assembly. A working assembly contains everything previously dispatched to the authority, minus anything replaced or withdrawn. It also includes anything incremental to that sequence that is planned but not yet submitted.

    Create

    Supporting

    Sequence

    Assembly

    		 Use this option to create a supporting sequence assembly. This type of assembly may be created within an Application alongside an existing Sequence Lifecycle without having to be part of that life cycle. The supporting sequence assembly will have no relationship to the previous life cycle, and will not contain any of the previously dispatched folders or files. You may use this type of assembly for any publications that are related to the Application, for example: paper submissions, or study reports.
  2. In the Assembly tab, click Create Supporting Sequence Assembly.
  3. Complete the necessary information and click Create.

    Note: It is recommended that you name the supporting sequence assembly appropriately to identify its relationship to the eCTD.

    The Create Assembly page appears.

  4. The new supporting assembly is created, and you can now import an assembly, add volumes, files, and folders.