Submission Plans

Submission Plans facilitate the creation of submissions for multiple similar applications.

In Ennov InSight , the submission plan is a single source scheme used to eliminate redundant tasks of creating similar submissions while working with identical applications.

At this time, Submission Plans are for use with Grouped Submissions only.

To use the Submission Plan wizard, you must meet the following security requirements:

— An Electronic Lifecycle Publishing (ELP) and Submission Planning and Tracking (SPT) license modules with at least WRITE privileges.

— At least WRITE privileges on Submission Plan to be able to create a Submission Plan entity from the New menu.

— At least WRITE privileges on Submission Plan to be able to modify a Submission Plan entity.

— At least ADMIN privileges on Submission Plan to be able to delete a Submission Plan entity.

— At least READ privileges on Submission Plan to be able to view a Submission Plan entity.

— At least WRITE privileges to Submission Plans to be able to disassociate an Application.

— At least WRITE privileges to Submission Plans to be able to disassociate an Event.

— At least WRITE privileges to Submission Plans to be able to disassociate a Sequence.

— Home Page Access for Submission Plan set to YES to access the Submission Plan from the Home Page tab. An Assembly Plan can be created with at least WRITE privileges on Submission Plan.

Submissions Plans are available with the Electronic Lifecycle Publishing (ELP) and Submission Planning and Tracking (SPT) license modules.

With a submission plan, you can:

— Scheme the submission structure and the content.

— Automatically transfer the structure and documents to the applications.

To create a submission plan, you must have appropriate privileges from your application security administrator.

Create Submission Plan Wizard

The Create Submission Plan wizard guides you through the process to create a submission plan and associate entities such as applications, events, and sequences to the submission plan.

To use the Create Submission Plan wizard, you must have appropriate privileges from your application security administrator.

Using the Create Submission Plan wizard, you can:

— Create submission plan

— Associate existing applications to the submission plan

— Create new events and associate them with the submission plans, or associate existing events to the submission plan

— Create new sequences and associate them with the submission plans, or associate existing sequences to the submission plan

To create submission plan using the wizard:

1. On the home page, click Wizard > Create Submission Plan.
2. On the Submission Plan Creation page, enter the attribute values for the submission plan and click Next. The application page appears.

   — For description of the submission plan attributes, see the topic Submission Plan Attributes.

3. Do one of the following:

   Option	Action
   To search for the application to associate:	Enter the relevant details in the respective fields (for description of the attributes in the Search for Applications to Associate page, see the topic Associating Applications to Submission Plans. Click Next.
   To view the list of existing US applications that have the application type selected for the submission plan:	Click Next.

4. Select the application and click Next.
5. On the confirmation page, click Next.

   The Confirmation pages appear during the execution of the wizard that indicate entities are being created, even though the wizard is still in progress. If the wizard prematurely terminates after a confirmation screen is displayed, the entities created continue to exist in Ennov InSight .

6. On the Summary page, to create or associate events and sequences, click Next and move to next step. Otherwise, click Finish to create the submission plan.
7. Choose the applicable procedure in the table below to enter an electronic signature in wizards:

   Scenario	Steps
   When electronic signature and SSO are enabled	In the confirmation page, select a reason and enter comments for the reason. Click Next. Validate your identity by entering your user credentials in the dialog box.
   When electronic signature is enabled and SSO is disabled	Select a reason and enter comments for the reason. Enter user ID and password and click Next.

1. On the Create/Associate Events page, select an appropriate option and follow the wizard to associate new or existing events to the submission plan.

   For the description of the event attributes, see the topic Event Attributes.

2. Choose the applicable procedure in the table below to enter an electronic signature in wizards:

   Scenario	Steps
   When electronic signature and SSO are enabled	In the confirmation page, select a reason and enter comments for the reason. Click Next. Validate your identity by entering your user credentials in the dialog box.
   When electronic signature is enabled and SSO is disabled	Select a reason and enter comments for the reason. Enter user ID and password and click Next.

1. On the Create/Associate Sequences page, select an appropriate option and follow the wizard to associate new or existing sequences to the submission plan.

   For the description of the sequence attributes, see the topic Sequence Attributes.

2. Choose the applicable procedure in the table below to enter an electronic signature in wizards:

   Scenario	Steps
   When electronic signature and SSO are enabled	In the confirmation page, select a reason and enter comments for the reason. Click Next. Validate your identity by entering your user credentials in the dialog box.
   When electronic signature is enabled and SSO is disabled	Select a reason and enter comments for the reason. Enter user ID and password and click Next.

1. Click Finish.

The submission plan is created.

Create Submission Plans

Ennov InSight enables you to create submission plans and associate entities such as applications and sequences to the submission plans.

To create a submission plan, you must have appropriate privileges from your application security administrator.

To create a submission plan:

1. On the home page, click New > Submission Plan.
2. On the Create Submission Plan page, enter the attribute values for the submission plan.
3. Save.
4. Choose the applicable procedure to enter an electronic signature for entities:

Modify Submission Plans

You can modify a submission plan to make edits to the attributes that were entered when the submission plan was created.

Note: When modifying the values for the submission plan it is not possible to modify the following fields: Submission Plan Type, DTD/Schema, Filing Type, and Submission Plan Countries.

To modify a submission plan:

1. On the home page left panel, click Submission Plans.
2. Click a link for the submission plan you want to modify.
3. On the View Submission Plan page, click the Edit icon.
4. On the Edit Submission Plan page, enter your changes to the submission plan attributes.
5. Click Save.
6. Choose the applicable procedure to enter an electronic signature for entities:

Delete Submission Plans

Users with administrator privileges can delete a submission plan from Ennov InSight . When a submission plan is deleted, its associated tasks and references will be deleted.

A submission plan with an associated assembly plan cannot be deleted. To delete a submission plan, the assembly plan associated to it must be deleted first.

To delete a submission plan:

1. Navigate to the submission plan you want to delete.
2. Click the link for the submission plan.
3. On the View Submission Plan page, click the Delete icon.
4. Select a reason and enter comments for the reason.
5. Click Next.
6. Choose the applicable procedure to enter an electronic signature for entities:

Submission Plan Attributes

You can use the attribute descriptions to enter the attribute values while creating the submission plans.