GPP Wizard: New Clinical Trial Projects
The
Global Project Planning (GPP) wizard enables you to create the following:
- Clinical trial authorization (CTA) and investigational new drug (IND) applications
- CTA applications and events for IND applications
- Events for CTA applications and IND applications
The applications and events that the GPP wizard creates for a clinical trial project are associated with the same clinical trial data.
If possible, the GPP wizard assigns an applicant ID to each application that it creates:
- If a default applicant ID is defined for the region associated with an application, the GPP wizard assigns the default applicant ID to the application. To set the default, go to . This default is not shown in the GPP wizard.
- If a default applicant ID is not defined for the region associated with an application, the GPP wizard does not assign an applicant ID to the application.
You can use a timeline/event plan to create the events for the project, and you can select a timeline/event plan type for the timeline/event plan:
- If you select an event type timeline/event plan, the GPP wizard creates an event that will have a sequence of statuses relevant to the event type that you select.
- If you select a procedure type timeline/event plan, the GPP wizard creates an event that will have a sequence of statuses relevant to the procedure type that you select.
- If you do not use a timeline/event plan, the GPP wizard creates an event that can have any sequence of active statuses.
You can associate other entities with the project. These entities include comparators, sequences, and a new PDS based on a PDS template.