Standalone Assemblies

A standalone assembly is an assembly that is not associated with an application or sequence.

It has no regulatory context and is not slated for submission to a specific agency, or part of an eCTD life cycle.

Examples of standalone assemblies are reports, eCTD modules that will be submitted later, and assembly templates that are used to create assemblies submitted in different countries and regions.

After you have created a standalone assembly it becomes available in lists of standalone assemblies. The assembly is also available in various queries.

In the standalone assembly created from an Assembly File, or Template, Assembly or View, each imported Leaf Element is assigned automatically with the default Leaf Status value from Data Administration.

Note: Only authorized users can access the assemblies.

Create an Empty Standalone Assembly

An empty standalone assembly provides the structure for a new standalone assembly without existing documents. You can use the Home page to create a standalone empty assembly. You can also use the Create eCTD wizard.

Note: You must have the appropriate security privileges to create a standalone assembly.

To create an empty standalone assembly:

  1. On the home page, click New > Standalone Assembly.
  2. On the Create Assembly page, select New (Empty) to create an empty assembly.
  3. Click the publishing settings library to use with the assembly.
  4. Save.
  5. Enter attribute values for the assembly. See Assembly Attributes.

    Note: The Created From attribute is always blank.

  6. Click Create.

Creating a Standalone Assembly from a Template, Assembly, or View

You can use the Home page to create an assembly based on a template, assembly, submitted, or approved view. You can also use the Create eCTD wizard.

Note: You must have the appropriate security privileges to create a standalone assembly.

To create an assembly based on a template, assembly, or a submitted or approved view:

  1. On the home page, click New > Standalone Assembly.
  2. On the Create Assembly page, click Existing Template, Assembly or View.
  3. Click Browse.
  4. Find and select the template, assembly, or view. Do either of the following:
    Option Action
    On the Search tab: Use the Search Assembly wizard.
    Option Action
    On any other tab: Click the versions or view types from which you want to select an assembly. Select an assembly.

    Note: If you click Show, you can select only the assembly root. You cannot create an assembly from any other node.

  5. For Use Source Publishing Settings Library, click Yes or No to indicate whether the new assembly will use the publishing settings library that the source assembly uses.
    Option Action
    If you clicked Yes, then for Import Publishing Elements: Click Yes.
    To indicate whether the new assembly will use the publishing elements that the source assembly uses: Click No.
    If you clicked No for Use Source Publishing Settings Library: Click the publishing settings library that the new assembly will use.
  6. For Retarget Copied Reference Leafs, click a value to retarget (change) or preserve the destinations of links in the reference leafs that are copied to the assembly that you create.
  7. Save.
  8. Enter attribute values for the assembly.
  9. Click Create.

Create a Standalone Assembly from an Assembly File

When you import an assembly file, the documents in the file are not automatically synchronized with the mapped

DMS.

They appear as placeholders which prevents import failures if the referenced DMS does not exist in the current system. Run a DMS synchronization immediately after importing to assign placeholders automatically to the DMS documents.

Note: You must have the appropriate security privileges to create a standalone assembly.

You can use the Home page to create a standalone from an assembly file. You can also use the Create eCTD wizard.

To create a standalone assembly based on an assembly file:

  1. On the home page, click New > Standalone Assembly.
  2. On the Create Assembly page, click Assembly File.
  3. To find the assembly file, click Browse and do either of the following:
    Option Action
    On the Documents tab, navigate to the assembly file: Click OK.
    Option Action
    On the Search tab, find the assembly file: Click OK.
  4. For Use Source Publishing Settings Library, click Yes or No to indicate whether the new assembly will use the publishing settings library that the source assembly uses.
    Option Action
    If you clicked Yes, then for Import Publishing Elements: Click Yes.
    To indicate whether the new assembly will use the publishing elements that the source assembly uses: Click No.
    If you clicked No for Use Source Publishing Settings Library: Click the publishing settings library that the new assembly will use.
  5. Save.

Create a Standalone Assembly from a Virtual Document

You can use the Home page to create a standalone assembly based on a virtual document. You can also use the eCTD wizard.

Note: You must have the appropriate security privileges to create a standalone assembly.

To create a standalone assembly based on a virtual document:

  1. On the home page, choose New > Standalone Assembly.
  2. On the Create Assembly page, click Virtual Document.
  3. To find the virtual document, click Browse and do either of the following:
    Option Action
    To search for a virtual document: On the Documents tab, navigate to the virtual document, and click OK.
    To search for a virtual document: On the Search tab, find the virtual document, and click OK.
  4. Click the publishing settings library to use with the assembly.
  5. Save.
  6. Enter attribute values for the assembly. See Assembly Attributes.
  7. Click Create.