Creating Clinical Programs

The clinical program is the highest-level initiative in Siebel Clinical. You associate protocols, regions, sites, and subjects with a program.

You can associate multiple regulatory applications with a program. You create these application records. Before you can create an application record, you must define the product that is associated with the application. For more information about defining products, see Siebel Life Sciences Guide.

This task is a step in "Process of Managing Clinical Trials".

To create a clinical program  

1. Navigate to the Administration - Clinical screen, then the Program List view.

2. In the Program list, create a new record and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   Program	Type the name of the clinical program.
   Mechanism	Select the partners associated with the clinical program.
   Application	Select a record containing details of the application for the clinical program. If necessary, create an application record. This record contains values for the following fields: Number. The number assigned to the application when it is submitted to the regulatory agency, for example the (A)NDA or IND number. Type. The type of application, such as CTN, IND, or CTX. Sub-Type. The application filer, for example, a company or an investigator. Filed. Whether the application is filed with the specified regulatory agency. Product. The applicable product for the application. You must complete this field before you can create a protocol for the program. Indication. The clinical indication for the application.

   
   

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