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

Setting Up 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 Clinical Administration screen > 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 may 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 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. For more information, see About Subject Enrollment Information Roll-Up.
   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 may 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 may be overwritten here at the Region level.

3. To add team members to the region, click the select button in the Team field, select a name in the Team picklist and click Position Rollup.

   The team member is automatically added to the protocol to which the region belongs.

4. Create a region record for each country or geographical area where there are or will be sites participating in the protocol.
5. (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.