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

Setting Up Clinical Regions

Clinical trials are often global, taking place in multiple countries. It is useful to track and view study data by country and region. The region level in Siebel Clinical allows you to do this.

Regions are optional for protocols. However, if you choose to use regions, by flagging 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 flag has been selected for the protocol. See Regions Required.

To create region records for a protocol

1. Navigate to the Administration - Clinical screen, then the Region List view.
2. In the Regions list, create a new record, and complete the necessary fields.

   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).
   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	Check this flag when there is no site information available under a region. Only summary information on 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. See Step 3 for information on entering.
   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 Protocol Withholding Amount. However, the Protocol Withholding Amount can be overwritten here at the Region level.
   Withholding Percentage	The percentage to be withheld from each of the payments to the investigators until the trial is complete. The default value is the Protocol Withholding Amount. However, the Protocol Withholding Percentage can be overwritten here 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.
4. Select a name in the Team picklist, and click Add to move the member to the Selected pane.
5. Click Position Rolldown.

   Multiselected team members are automatically added to all the site teams of this region.

   NOTE:  The Position Rolldown button for region applies only to the sites below a region.

6. Click Position Rollup.

   Multiselected team members are automatically 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.

7. Create a region record for each country or geographical area where there are or will be sites participating in the protocol.
8. (Optional) Drill down on the region field and add extra information using the More Info tab view.

   NOTE:  It is important to specify the Currency Code for each region if multiple currencies will be used for the trial.