Grouped Submissions

With DTD version 3.3 for the FDA, sponsors have the ability to create submissions that correspond to multiple applications. These are called grouped submissions. These submission behave differently when loading and deleting, in comparison to regular submissions.

Grouped submissions originate in one application that are then used in other applications. As a result, there is a primary application and the secondary application(s). When loading a grouped submission, it will be automatically loaded into the secondary application(s) as well. Similarly, when a grouped submission is deleted from a primary application, that same submission is automatically deleted from the secondary application as well. The following error message will appear on the Status page of VALIDATE when attempting to delete a grouped submission from a secondary application(s). The number in parentheses at the end of the message is the primary application.

Validate_GroupSub

Grouped submissions will be identified once they are loaded/processed. If unprocessed, VALIDATE will display the sequences like regular submissions.

Validate_GroupUnprocessed

Once loaded, the Sequence column displays (Grouped) to show the applicable sequence is part of a grouped submission.

Validate_GroupProcessed


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