Creating Satellite Sites for Clinical Trials

The satellite site is a study site that is linked to an existing parent site where the parent site and the satellite site share the same principal investigator. Subjects are seen by the same principal investigator and visit both the parent site and the satellite site according to their own business requirements. Before starting to create satellite sites for clinical trials, review Managing Satellite Sites and Contacts for Clinical Trials for more information.

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

To create a satellite site for clinical trial

1. Navigate to the Site Management screen, then the Protocol Site List view.

2. In the Protocol Site Visits list, select My Sites in the visibility filter.

   All site visits that you own appear.

3. In the Protocol Site list, drill down on the Site Number field of the site under which you want to create the satellite site.

4. Navigate to the Satellites Sites view.

   This view contains the following information:

   • Subject Info. Shows the subject enrollment data accrued for a parent site from all the satellite sites under it.

   • Financials. Shows the financial data accrued for a parent site from all the satellite sites under it.

   • Satellite Sites. Lists all the satellite sites for the parent site and provides the ability to create a new satellite site for the parent site.

5. In the Satellites Sites list, create a new record and complete the necessary fields. Some data is inherited from the parent site and cannot be changed. Some fields are shown in the following table.

   Field	Comments
   Satellite Site Number	Type the number to assign to the satellite site.
   Account	Select the primary account (the institution where the protocol is managed) for the site. To change the primary account for the site, you select a different account in this field. For more information about adding other accounts to the site, see Associating Sites with Accounts.
   PI Last Name	Read-only field. The last name of the principal investigator, inherited from the parent site, for the satellite site. This is a read-only field.
   PI First Name	Read-only field. The first name of the principal investigator, inherited from the parent site, for the satellite site. This is a read-only field.
   Status	The status of the satellite site, which is Planned by default. Other statuses are Initiated, Enrolling, and Closed.
   Site Initiated	The date the satellite site was created. This field is blank by default.
   Site Terminated	The date the satellite site was terminated. This field is blank by default.
   Team	Read-only field. The team for the satellite site, inherited from the parent site. For more information, see Creating Sites for Clinical Trials (Step 3.).

6. Drill down on the Satellite Site Number field to complete more fields as necessary. Some data is inherited from the parent site and cannot be changed. Some fields are shown in the following table.

   Field	Comments
   Protocol #	Read-only field. The protocol, inherited from the parent site, for the satellite site.
   Region	Read-only field.The region, inherited from the parent site, for satellite site.
   Parent Site	Read-only field. The parent site for the satellite site.
   Versions	Read-only field.The version of the subject visit template, which is inherited from the parent site. Only one version can be active at a time. The active template is used when activities are generated for a subject. For more information about protocol versions, see Tracking and Revising Team Assignment History
   Exchange Date	Select the date that determines the exchange rate of the currency. By default, the exchange date for the site is the date that you create the site. You can change this date in response to changes in currency rates. However, changes to the exchange date at the site level take effect only when the exchange date also changes at the system level. For more information, see Siebel Applications Administration Guide.
   Withholding Amount	Type the amount of the total payment to withhold from the investigators until the trial is complete. You can set the default value at the region or protocol level, but you can overwrite the value at the site level.
   Withholding %	Type the percentage of the total payment to withhold from the investigators until the trial is complete. You can set the default value at the region or protocol level, but you can overwrite the value at the site level.
   Currency Code	Read-only field. The currency, inherited from the parent site, that is used to display the payments, costs, and budgets for the satellite site.
   Last Completed Visit Date	Select this field to use the date of the last completed visit for rescheduling subject visits. Deselect this field to prompt the user to enter a new start date for rescheduled visits. All uncompleted subject visits are rescheduled using the new date.

7. (Optional) Navigate to the More Info view to add more information. Some fields are shown in the following table.

   Field	Comments
   Address	Select one of the principal investigator’s addresses as the site address.
   # Screen Failure	Displays the number of subjects that fail the screening.
   Last Subject Off Study	Displays the date that the last subject completes the study. (This field is automatically rolled-up from the subject data.)
   First Subject Enrolled	Displays the date that you enroll the first subject in the study. (This field is automatically rolled-up from the subject data.)
   # Early Terminated	Displays the number of subjects who terminate the study before it is complete.
   Contract Amount	Displays the sum of all contract amounts for the site. For more information, see Associating Contracts with Sites.
   Paid To Date	Displays the amount of money that you paid to date to the investigators.
   Earned To Date	The amount of money that investigators earned to date.
   Activate for Synchronization	Select this field to activate the site for synchronization. This field is required for integration with Oracle Health Sciences InForm. When this field is checked, a new integration object for the protocol site is sent to Oracle Health Sciences InForm. The integration object creates the site in Oracle Health Sciences InForm, or updates the site, if it already exists. This field is read-only until the following conditions are met: The Synchronize Active Study Sites field of the protocol is set to true. The Primary Site Address field is populated.
   Primary Site Address	Select the primary address for the site. This field sets the primary location of the site for the study in Siebel Clinical. The Addresses dialog box displays all addresses for the site. This field is required for integration with Oracle Health Sciences InForm, and populates the site address when the site is created in Oracle Health Sciences InForm.
   Satellite Site Count	Displays the number of satellite sites associated with this site.

8. Assign subject visits to the satellite site as follows:

   1. Navigate to the Subjects view.

   2. Create a new Subject record and complete the necessary fields.

   3. Drill down on the Screening # field.

   4. Create a new Visit Plan record and complete the necessary fields. Some fields are shown in the following table. For more information about subjects visits, see Defining Subject Visits.

      Field	Comments
      Site	Select the site for the subject visit. The Sites pick list includes the parent site and all satellite sites under the parent site.
      Assigned To	Select the user ID of the person assigned to the subject visit.
      Sequence	Type the sequence number of the visit.
      Type	Read-only field. The type of visit, which is Unscheduled Visit by default.
      Name	The name of the visit.

   5. Add Activities to the subject visit as required and complete the necessary fields. For more information about activities, see Defining Activities for Subject Visits and Associating Activities with Sites.

9. Transfer (uncompleted) subject visits to or from the satellite site as required:

   1. Navigate to the Subjects view.

   2. Drill down on the Screening # field.

      The Visits view of the Subjects screen appears showing the Visit Plans.

   3. In the Site field, select the site to which you want to transfer the (uncompleted) subject visits to.

      The Sites pick list includes the parent site and all the satellite sites under the parent site. You can transfer subject visits from one satellite site to another satellite site or to the parent site as required. For more information about transferring subjects, see Transferring Clinical Subjects.

   4. Navigate to the Transfer History view and review all subject transfers against the subject.

      The Transfer History view includes the following information for each subject transfer: Source Site Name, Destination Site Name, Transfer Date, Transferred By, Status at Transfer, Description.

10. Navigate to the Site Management screen, then the Subject Transfer History view and review all subject transfers against the site.

    • The Subject In applet lists all subject visits transferred to the site.

    • The Subject Out applet lists all subject visits transferred from the site.