Creating Protocols

The following procedure shows how to create a protocol using Siebel Clinical task-based UI.

To create a protocol

  1. Click the Tasks icon on the application taskbar to open the Task Pane applet for Siebel Clinical.

  2. Click Create Protocol in the Task Pane applet.

  3. Enter protocol data on the page that appears - the fields are described in the following table.

    Field

    Description

    Program

    Select the name of the program for the clinical trial.

    Product

    Select the product for the clinical trial. You can select only the products that are associated with the clinical program.

    # Planned Sites

    Type the number of planned sites for the protocol.

    # Planned Subjects

    Type the number of planned subjects for the protocol.

    Regions Required

    Select this check box only if the sites for the protocol must belong to a region (and see Creating Protocols and Regions for more information). When you select this check box, you cannot create sites directly under protocols. You must create regions first, and then create sites that are associated with regions.

    Deselect this check box to indicate that the sites for this protocol must not belong to a region.

    Protocol #

    Type an identifying number for the protocol.

    Phase

    Select the phase of clinical trial, such as, Phase I, II, or III.

    Status

    Select the protocol status, such as, Planned, In Progress, or Completed.

    Type

    Select the purpose of the protocol.

    Title

    Type a descriptive title for the protocol.

  4. If required, click Pause at any time to pause the task.

    The task moves to your Inbox where you must go when you want to resume work on the task.

  5. If required, click Cancel at any time to cancel the task.

  6. Click Submit to submit the task - that is, create the new protocol.