Event Maintenance

Event values appear in selection lists on the Event Attributes page and are designated when an event is created. You can use Data Administration to add and modify event attribute values, and to set the status of a value to active or inactive.

When you select a value under Event 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 event maintenance values.

Event Maintenance: Event Values

Ennov InSight lets you use Data Administration to add and modify Event values and attributes, and to set statuses on those attributes.

You can create and maintain the following Event values:

Action Type Attributes

To define an action type value, enter values for the following attributes:

EU Grouping or Worksharing Attributes

To define a EU grouping or worksharing activity value, enter values for the following attributes:

Event Status Attributes

To define an event status value, enter values for the following attributes:

Event Type Attributes

To define an event type value, enter values for the following attributes:

PSUR Report Code Attributes

To define a PSUR report code value, enter values for the following attributes:

Secondary Event Type Attributes

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

Timeline/Event Plan Type Attributes

To define a timeline/event plan type value, enter values for the following attributes:

Timeline/Event Plan Attributes

To define a timeline/event plan value, enter values for the following attributes:

Timeline/Event Plans and Country Lead Times

In Ennov InSight , a timeline/event plan is an ordered set of milestones that you define for an event. The ordered milestones in a timeline/event plan represent the progression of event statuses you expect to occur for an event. You have the option to apply a timeline/event plan when creating an event.

Note: The set of event statuses can vary depending on the regulatory action taking place or on the procedure type.

Country lead times is a feature that enables you to predefine a default interval of days on a per country basis for each event status in a timeline/event plan. The lead times are tracked in a table on the Timeline/Event Plan page that displays all of the event statuses per country in the order defined for the timeline/event plan.

You can create a timeline/event plan by using the Timeline/Event Plan Wizard.

Use the Create Timeline/Event Plan Wizard

You can create a timeline/event plan using the Create Timeline/Event Plan wizard.

Note: Access to the Create Timeline/Event Plan wizard is established in Ennov InSight Security Administration. In the Home Page Access section, the Data Administration option must be set to Yes for the user.

To create a timeline/event plan:

1. Start the Create Timeline/Event Plan wizard using one of the options:

   — Wizards > Create Timeline/Event Plan .

   — On the upper navigation pane, choose GO TO > Data Administration. Under Event Maintenance, click Timeline/Event Plan Values. Click the Create icon.

2. On the Enter Timeline/Event Plan Details page: — Select a timeline/event plan type.

— Enter a timeline/event plan name.

— Select the event type or procedure type.

— Select the region type of the region, containing the countries for which you will use the timeline/event plan. — Select the region that belongs to the selected region type.

— Select the countries for which you will use the timeline/event plan.

— In the Enforce Status Progression field, select Yes or No. Enforcing a status progression limits the statuses an event country schedule can transition to. It is based on the progression setup in the timeline/event plan when the event was created.

— Select the required event statuses for which you want to specify lead times in the timeline/event plan.

— Optionally, select the optional event statuses for which you want to specify lead times in the timeline/event plan.

1. Click Next.

   The Create Timeline/Event Plan Confirmation page opens.

2. Click Next.

   The Enter Lead Times Values page opens.

3. Enter a lead time for each event status.

   To select a Lead Time field, double-click it.

4. Click Next.

   The Create Timeline/Event Plan Lead Time Confirmation page opens.

5. Click Next.

   The Create Plan Summary page opens.

   Note: The timeline/event plan is a hyperlink to the created Timeline/Event Plan Attributes page.

6. Click Finish.

Prepare to Modify a Timeline/Event Plan

You can modify a timeline/event plan to change the progression of event statuses you expect to occur for an event. However, certain configurations must be performed before you modify a timeline/event plan. The configurations to be performed are:

— To use the Change Approval wizards with events created from a timeline/event plan, the Approved and Not Approved statuses must be included in the timeline/event plan.

— To use the Change Submittal wizards with events created from a timeline/event plan, the Submitted status must be included in the timeline/event plan.

— If you move an event status from the Event Statuses Selected multi-select box to the Event Statuses Available multi-select box for Event Statuses, and then move that same status from Event Statuses Selected to Event Statuses Available for Optional Event Statuses, an error message appears after you click Save. Instead, click Save immediately after moving the event status from Event Statuses Selected to Event Statuses Available for Event Statuses, and then resume modifying the timeline/event plan to move the event status from Event Statuses Selected to Event Statuses Available for Optional Event Statuses. Click Save again when you have completed your additional modifications.

Modify a Timeline/Event Plan

You can modify a timeline/event plan from the Data Administration page.

To modify an existing timeline/event plan:

1. In Ennov InSight , click Go To > Data Administration.
2. On the Data Administration page, under Event Maintenance, click Timeline/Event Plan Values.
3. On the Timeline/Event Plan main page, click the link for the timeline/event plan that you want to modify.
4. Click the Edit icon to modify the timeline/event plan.

   The initial fields for modifying a timeline/event plan are displayed.

   

5. On the Timeline/Event Plan page, do one of the following:

   Action	Procedure
   Enter your changes to the timeline/event plan attributes	Click Save.
   To add this timeline/event plan to these drop-down lists and selection boxes	Click Activate.
   To hide this timeline/event plan from the drop-down lists and selection boxes where you would be selecting an timeline/event plan value	Click Deactivate.

6. You are returned to the Timeline/Event Plan Attributes page.

Timeline/Event Plan Attributes

Use the timeline/event plan attribute information to select and enter the appropriate values while you define and modify timeline/event plans. The table describes the timeline/event plan attributes that are available when you define a timeline/event plan.

If there are multiple Event-Country Statuses with the same actual date, then the following business logic determines the displayed current status:

— If the statuses have different last modified dates, the status with the most recent modified date is the current status

— If the statuses have the same last modified date, the last status in the status order is the current status

View Timeline/Event Plans

You can view a timeline/event plan, as well as perform changes to a timeline/event plan and the lead time for timeline/event plan countries, in Data Administration.

To view a timeline/event plan:

1. In Ennov InSight , click Go To > Data Administration. The Data Administration page appears.
2. On the Data Administration page, under Event Maintenance, click Timeline/Event Plan Values. The Timeline/Event Plan page appears.
3. On the Timeline/Event Plan page, click the link for the timeline/event plan to view.
4. On the Timeline/Event Plan view page, do any of the following:

If there are multiple Event-Country Statuses with the same actual date, then the following business logic determines the displayed current status:

Add Timeline/Event Plan Countries

You can add countries to an existing timeline/event plan in Data Administration to associate the timeline/event plan to the added countries.

To add countries to an event plan:

1. In Ennov InSight , click Go To > Data Administration. The Data Administration page appears.
2. On the Data Administration page, under Event Maintenance, click Timeline/Event Plan Values. The Timeline/Event Plan page appears.
3. On the Timeline/Event Plan page, click the link for the timeline/event plan to which you want to add countries.
4. On the Timeline/Event Plan Countries tab, click the Add Countries icon.

   The Timeline/Event Plan Countries page appears.

   

5. To add countries to the timeline/event plan, select countries in the Countries Available box and move them to the Countries Selected box.

   The default lead times for the countries that you add are ₀.

6. As an option, you can apply the default lead times for another country to the country that you are adding. In the Copy Default Lead Times from the following Country list, select the country that has the default lead times that you want to apply.

   If you do not select a country lead time to apply, the default lead times for the country that you add are ₀.

7. Click Save.

Remove Timeline/Event Plan Countries

To disassociate countries from an event plan, you can remove countries from an event plan in Data Administration.

To remove countries from an event plan:

1. In Ennov InSight , click Go To > Data Administration. The Data Administration page appears.
2. On the Data Administration page, under Event Maintenance, click Timeline/Event Plan Values. The Timeline/Event Plan page appears.
3. On the Timeline/Event Plan page, click the link for the event plan from which you want to remove countries.
4. On the Timeline/Event Plan Countries tab, click the Delete Countries icon. The Timeline/Event Plan Countries page appears.
5. To remove one or more countries from the timeline/event plan, select countries in the Associated with Plan box and move them to the Disassociated from Plan box.
6. Click Save.

Modify Lead Times for Timeline/Event Plan Countries

You can modify the number of days that represent the lead time for an event status for a country. Country lead times are not defined for optional event statuses.

To modify lead times for countries in a timeline/event plan:

1. In Ennov InSight , click Go To > Data Administration.
2. On the Data Administration page, under Event Maintenance, click Timeline/Event Plan Values.
3. On the Timeline/Event Plan page, click the link for the timeline/event plan whose country event status you wish to modify.

   

4. In the Timeline/Event Plan Countries table, click the appropriate country link for the event status that you want to modify for that country.

   

5. In the Lead Time box, enter the number of days lead time for the country and event status.
6. Click Save.

The modified lead time value for the country and event status appears on the Timeline/Event Plan Countries tab.

Event Attributes

Events represent key business objectives or regulatory actions for an Application. The attributes describe the type of Event and the Event details.