Grouped Submissions
A grouped submission is a submission type that is created and managed using submission plans. It is an eCTD submission where all files referenced in it are applicable to multiple applications identified as parts of the group.
Content of the grouped submission physically resides in one application. This is considered the Application Containing Files, or primary application, and remains constant in future sequences. Consider the following constraints while grouping a submission:
- Grouped submissions are supported using US DTD 3.3 or higher versions only.
- All submissions within a group must have the same application and submission type.
Note: The application type and submission type of the submission are limited by the agency. Please check the latest version of the specification for the list of types applicable for grouped submissions.
- The initial submission within a grouped submission can only contain new leafs.
- Subsequent submissions within a grouped submission can only contain new leafs or lifecycle operations against previous submissions within that group.
In
Calyx RIM, all data related to the grouped submission is maintained in the submission plan entity with the Grouped Submission type. This includes:
- Applications, events, and sequences included in the grouped submission.
- Tasks and references related to the grouped submission.
- Assembly Plans that keep the structure, lifecycle, content, and metadata of the eCTD submission.