Siebel Life Sciences Guide > Setting Up and Carrying Out a Clinical Trial > Administrator Procedures >

Creating a Clinical Program

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

Multiple regulatory applications can be associated with a program.

To add a new clinical program

  1. From the application-level menu, choose View > Site Map > Clinical Administration > Clinical Programs.
  2. In the Clinical Programs list, add a record, and complete the necessary fields.

    3. NOTE:  Before you can create an application, the associated product must be correctly defined as type Compound. For more information about defining products, see Managing Products.

    Some of the fields in a Clinical Programs record 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. The choices in this drop-down list are configured by using the CLNCL_PROG_INDICATION type in the List of Values.
    Number. The number assigned to the application when submitted to the regulatory agency. More than one application number may be assigned to a program.
    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. The choices in this drop-down list are configured by using the CLNCL_PROG_APPL_SUBTYPE type in the List of Values.
    Type. The type of application, such as CTN, IND, or CTX. The choices in this drop-down list are configured by using the CLNCL_PROG_APPL_TYPE type in the List of Values.
    Mechanism
    Partners associated with the clinical program. The choices in this drop-down list are configured by using the CLNCL_PROG_MECHANISM type in the List of Values.
    Program
    The name of the clinical program.

  3. Optional: Click the Attachments view tab, and attach files associated with the clinical program.

 Siebel Life Sciences Guide 
 Published: 18 April 2003