Siebel Clinical Trial Management System Guide > Setting Up a Clinical Trial >

Creating a Clinical Program

The clinical program is the highest-level initiative in Siebel Clinical. Protocols, regions, sites, and subjects must be associated with a program.

Multiple regulatory applications can be associated with a program.

To create a new clinical program

1. Navigate to the Clinical Programs screen, then the Program List view.
2. In the Clinical Programs list, create a new record, and complete the necessary fields.

   NOTE:  Before you can create an application, the associated product must be correctly defined. For more information about defining products, see Siebel Life Sciences Guide.

   Some fields are described in the following table.

   Field	Comments
   Application	A multi-value field containing details of the application. Filed. Whether the application has been filed with the specified regulatory agency. Indication. The clinical indication for the application. Number. The number assigned to the application when submitted to the regulatory agency, for example the (A)NDA or IND number. Product. This field must be completed before a protocol can be created for the program. Sub-Type. Who filed the application. For example, a company or an investigator. Type. The type of application, such as CTN, IND, or CTX.
   Mechanism	Partners associated with the clinical program.
   Program	The name of the clinical program.

3. (Optional) Drill down on the new record and associate files with the clinical program.