Functions of Change Submittal Status Wizard

Use Change Submittal Status wizard to update all entities simultaneously to reflect in Ennov InSight once a submission is submitted.

The following are the activities and functions of the Change Submittal Status wizard:

— Confirmed Sequence Code is adjusted to eCTD 4.0 standard type.

— The value starts with '1' and each subsequent sequence number is increased by 1. The Confirmed Sequence Code field is pre-populated based on the type of a sequence in application when using the wizard from an application or an event. If both eCTD 3.2 and eCTD 4.0 sequences are present in an application, the field is prepopulated with the eCTD 4.0 Code value.

— After the Change Submittal Status wizard is used for Initial Sequence Assembly with the Lifecycle checkbox selected/ for Working Assembly, summary of the Change Submittal Status for an assembly is displayed under Job Requests.

— Sequence Code is updated to the Confirmed Sequence Code value.

— Sequence Status is updated to Submitted.

— Sequence Status Date is updated to the entered Submittal Date.

— For initial assembly if Lifecycle checkbox is checked the assembly is getting locked and added to lifecycle.

— For Working Assemblies assembly is locked and added to Lifecycle.

— Assembly Status is updated to Effective status (by default it is Approved).

— Assembly Status Date is updated to the entered Submittal Date.

— For Initial Sequence Assembly without the Lifecycle option selected:

Submissions

  • when no assembly exists: the 'Change submittal status for Assembly Name' Job is not created. Sequence Code, Sequence Status and Sequence Status Date are updated.
  • If assembly exists: assembly is locked, but not added to Lifecycle, assembly status and Status Date are updated.

The Change Submittal Status wizard can be used when:

— There is no Event associated with a Sequence.

— Several Events are associated with a Sequence (the date and status are updated for all events).

— Sequence Code and Sequence Status Date can be updated when re-running the Change Submittal Status wizard.