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

Setting Up Clinical Regions

Clinical trials are often global, taking place 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 it provides 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 has been 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 there are or will be sites participating in the protocol.

   Some fields are described in the following table.

   Field	Comments
   Currency Code	The currency that is used to display the payments, costs, and budgets in the Regions screen. 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.
   Exchange Date	The date that determines the exchange rate of the currency used. By default, the exchange date for the region is the date the region is created. This date can be changed in response to changes in currency rates. However, changes made 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.
   No Site Info	Select this field when there is no site information available under a region. Only summary information about site enrollment is available for such a region.
   Protocol #	Only protocols where regions are required are listed in the Pick Protocol dialog box.
   # Planned Sites	Number of sites planned for the region.
   # Planned Subjects	Number of subjects planned for the region.
   Protocol Region	A name for the region. This is automatically filled in with the protocol number and the region name.
   Region	Geographic region to which the site belongs.
   Team	Team members associated with the protocol to which the region belongs. For more information, see Step 3.
   Withholding Amount	The amount to be withheld 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, the Withholding Amount field for the protocol can be overwritten in this field at the region level.
   Withholding %	The percentage to be withheld from each of the payments to the investigators until the trial is complete. The default value is the Withholding % field for the protocol. However, the Withholding % field for the protocol can be overwritten in this field at the region level.

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 below 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 have worked on a protocol in a region and what their role was, 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.

About Automatically Assigning Team Members Using the Position Rollup and Rolldown Buttons

When you use 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 had been assigned manually. 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 who has worked 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.