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

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 eClinical 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 add regions to a protocol

  1. From the application-level menu, choose View > Site Map > Clinical Administration > Regions.
  2. In the Regions list, add a record, and complete the necessary fields.

    3. Some of the fields in a Region record 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.
    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.
    Name
    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.
    The choices in this drop-down list are configured by using the CLINICAL_REGION type in the List of Values.
    Team
    Team members associated with the protocol to which the region belongs. See Step 3 for information on entering.

  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.

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


 Siebel Life Sciences Guide 
 Published: 18 April 2003