Sequence Maintenance

Sequence values created in Data Administration appear in drop-down lists on the Sequence Attributes page and are designated when a sequence is created. Data administration enables you to add and modify drop-down list values, and set the status of a value to active or inactive.

When you select a value under Sequence Maintenance, a page opens with a table of all values that have been defined. You can sort these values by column. The default view is sorted in ascending, alphanumeric order.

Note: The proper data administration access privileges are required to view and modify sequence maintenance values.

Sequence Maintenance: Sequence Values

You can create and maintain the following sequence values:

Ennov InSight Administration 7.3 Sequence Maintenance

Filing Type Attributes

To define a filing type value, enter values for the following attributes:

Sequence Status Attributes

To define a sequence status value, enter values for the following attributes:

Ennov InSight Administration 7.3 Sequence Maintenance

Define Application Types Under Filing Type eCTD Code for Grouped Submissions

You can define the US FDA eCTD Module 1 Specification v2.3 / DTD v3.3 Grouped Submission application types using Filing Type Values in the Sequence Maintenance section in Data Administration.

Note: Please refer to the US Module 1 Specifications for the valid values to complete this procedure.

To define the application types for grouped submissions:

1. On the Ennov InSight home page, click Go To > Data Administration.
2. Under Sequence Maintenance, click Filing Type Values.
3. Click the Filing Type that you wish to update.
4. Under Applicable DTD/Schema, click us-3-3.
5. In the Types Valid for Grouped Submissions box, select the applicable Application Type(s).
6. Click >> to move the Application Type(s) to the Selected box.
7. Save.

The defined application types will be available for selection while creating submission plans for grouped submissions.