New CTA Applications and Create New Event for IND Applications

You can create new CTA applications and new events for IND applications with the Global Project Plan (GPP) Wizard. To create new CTA Applications and Create New Event for Existing IND Applications:

1. On the Select Products, Countries, and IND Application Statues page, define criteria for the applications that you want to create or for which want to create events:
   • 1. Select an Application Category from the drop-down list. The application category determines the application type.
     2. Select a Family Type.
     3. Select a Family Name.
     4. Optionally, select one or more Products to associate with the applications that you want to create.
     5. for Region Type, select the region type that includes the regions with countries for which you want to create applications.
     6. For IND Application Status, select the application statuses of the IND applications for which you want to create new events.
     7. For Region, specify the regions that include countries for which you want to create applications. The list of available countries is determined by the selected region type.
     8. For the Country attribute, select the countries for which you want to create applications and events. The list of available countries is determined by the selected regions. The list of available countries is further limited to the countries for which you have at least WRITE privileges for the product family that you selected, and to the countries with a default procedure type and application type defined for the application category that you selected.

1. Click Next.The Select CT Shared Data page appears.
2. Select the Clinical Trial Shared Data, which is identified by a protocol code number.
3. Click Next.The Enter Application Details page appears.
4. Enter or select values for the relevant application properties.The Associate IND Applications page appears.
5. Select the IND applications for which you want to create an event.
6. Click Next.The Enter Event Details page appears.
7. Enter or select values for the event attributes.The event-country status is assigned to each country when the event is created.
8. Click Next.The Select Timeline/Event Plan page appears.
9. On the Select Timeline/Event Plan page, do one of the following:

   Action	Option
   Select a timeline/event plan from the Timeline/Event Plan drop-down list to associate a timeline/event plan with the events that the wizard creates. If a timeline/event plan chosen in the project does not have a country lead time for the reviewing country on the selected application, the lead times in the status schedule table are assumed to be zero. Projected dates are calculated using zero lead times, and the project’s pivot status and status date.	Continue at step 11.
   Do not select a timeline/event plan. In this case, a timeline/event plan is not associated with the project	Click Next as many as is necessary to open the Confirmation page, indicating that applications and events will be created for the countries selected in step 1. Continue at step 12.

10. Click Next after completing each timeline/event plan page presented.After completing all timeline/event plan pages, the Confirmation page opens, indicating that applications and events will be created for the countries selected in step 1.
11. Click Next.The Associate or Create Additional Entities page appears.
12. On the Associate or Create Additional Entities page, do one or more of the following:

    Action	Option
    To associate comparators with the clinical trial application	Select Associate Comparators. Go to step 14
    To create a sequence	Select Create Sequence. Go to step 16.
    To create a PDS using a PDS template	Select Create a PDS using a PDS Template. Go to step 19.
    To close the wizard without associating additional entities with the CTA	Click Finish. You return to the view from which you invoked the GPP wizard.

13. Click Next.The Select Comparators page appears.
14. On the Select Comparators page, do the following:
    1. Select one or more comparators.
    2. Click Next.
    3. If you selected Create Sequence in step 13, go to step 17.
    4. If you selected Create PDS using a PDS Template in step 13, go to step 20.
    5. If you did not select other options in step 13, the Summary page opens. Click Finish to return to the view from which you invoked the GPP wizard.
15. Click Next.The Sequence Attributes page appears.
16. Select or enter values for the sequence attributes.
17. Click Next.A confirmation page opens, indicating that sequences will be created. Go to step 19.
18. Click Next.One of the following occurs:

    ◦ If you selected Create PDS using a PDS Template in step 13, the Select PDS Templates page appears.

    Go to step 20.

    ◦ If you did not select other options in step 13, the Summary page opens. Click Finish to return to the view from which you invoked the GPP wizard.

19. On the Select PDS Templates page, do the following:
    • 1. Select a product. The products available for you to select are limited to those that you selected in step 1.
      2. Select one or more PDS templates. Any predefined PDS templates for the selected product are displayed in the Available list box. Product details sets are created from each of the selected templates.

Note: A Ennov best practices is to create only one PDS per product per application, and to define different package sets in a PDS for the various presentations that go into packaging a product.

1. Click Next.A confirmation page indicates that product detail sets will be created for the templates selected in step 20.
2. Click Next.The Complete Additional Entities Creation page appears.
3. On the Complete Additional Entities Creation page, do one of the following:

To view the project after closing the GPP wizard, click Home > Projects tab. To open the Project Attributes page for the project that you just created, click the link.