Setting Up Clinical Regions

Clinical trials often occur in multiple countries. The region level in Siebel Clinical allows you to track and view study data by country and region.

Regions are optional for protocols. However, if you choose to use regions by selecting the Regions Required field in the protocol record, then each site associated with the protocol must belong to a region. One of the advantages of using regions is that regions provide another way of grouping sites and subjects. For example, you can chart subject enrollment by region in addition to by protocol and by site.

Note: You cannot create regions for a protocol unless the Regions Required field is selected for the protocol. For more information, see the description of the Regions Required field in "Setting Up Clinical Protocols".

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

To set up clinical regions 

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

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

   Create a region record for each country or geographical area where sites are or will be participating in the protocol.

   Some fields are described in the following table.

   Field	Comments
   Protocol #	Select the protocol for the region. Only protocols that require regions are listed in the Pick Protocol dialog box.
   Region	Select the geographic region to which the site belongs.
   Protocol Region	Displays the name of the region. This field is automatically populated with the protocol number and the region name.
   # Planned Sites	Type the number of planned sites for the region.
   # Planned Subjects	Type the number of planned subjects for the region.
   Team	Select the team members associated with the protocol to which the region belongs. For more information, see Step 3.
   No Site Info	Select this field to indicate that no site information is available under a region. Only summary information about site enrollment is available for such a region.
   Currency Code	Select the currency that is used to display the payments, costs, and budgets in the region. The default value is USD (United States dollars). Note: You must specify the currency code for each region if multiple currencies are used for the trial.
   Withholding Amount	Type the amount to withhold from each of the payments to the investigators until the trial is complete. The default value is the Withholding Amount field for the protocol. However, you can overwrite the Withholding Amount field for the protocol in this field at the region level.
   Withholding %	Type the percentage to withhold from each of the payments to the investigators until the trial is complete. The default value is the Withholding % field for the protocol. However, you can overwrite the Withholding % field for the protocol in this field at the region level.
   Exchange Date	Select the date that determines the exchange rate of the currency. By default, the exchange date for the region is the date that you create the region. You can change this date in response to changes in currency rates. However, changes to the exchange date at the region level take effect only when the exchange date also changes at the system level. For more information, see Siebel Applications Administration Guide.

   
   

3. To add team members to the region, click the select button in the Team field to open the Team dialog box, and complete the following steps:

   1. Move the record for an available team member to the list of selected team members.

   2. Click Position Rolldown.

      Multi-selected team members are added to all the site teams of this region.

      
      

      Note: The Position Rolldown button for region applies only to the sites after a region.

      
      

   3. Click Position Rollup.

      Multi-selected team members are added to the protocol to which the region belongs. To administer and track the history of team members who work on a protocol in a region and to determine their role, see "Tracking and Revising Team Assignment History".

   4. Click OK.

4. (Optional) Drill down on the Region field, and navigate to the More Info view to add more information.

Automatically Assigning Team Members Using the Position Rollup and Rolldown Buttons

When you click the Position Rolldown and Position Rollup button, a record is created, where applicable, in each of the Team History views for the protocol and all sites belonging to the region. The Position Rolldown mechanism automates the addition of team members to the Team History view for sites and the Team History view for protocols as if they are manually added. To remove a team member from the protocol, see "About Removing Team Members From the Team of a Protocol".

Creating Assignment Team History for Regions

The Team History view allows you to administer and track team members who work in the region. It also provides details about the roles as well as the start and end dates.

To create assignment team history for a region  

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

2. In the Region list, drill down on the Region field of the region for which you want to create a new team assignment history.

3. Navigate to the Team History view.

4. In the History list, create a new record and complete the necessary fields.