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 lifecycle.

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.