Creating Sites for Clinical Trials

The site is an account that a principal investigator manages for a particular protocol. In Siebel Clinical, a separate site record must exist for each unique combination of a protocol, account, and principal investigator. Before starting to create sites for clinical trials, review Process of Managing Sites and Contacts for Clinical Trials for more information.

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

To create a site for clinical trials

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

2. In the Protocol Site list, create a new record and complete the necessary fields. Some fields are shown in the following table.

   Field	Comments
   Favorite	Select this field and then select the star icon that appears to indicate that this site is a favorite. Deselect the star icon to remove the star icon from the Favorite field. A star icon appears in the Favorite field of each favorite site. Favorite sites appear first in the Protocol Site List.
   Satellite Site	Read-Only field. A star in this field indicates that this is a satellite site.
   Site #	Type the number to assign to the site. This field is not required when the Status field for the site is Planned or Not Initiated. This field becomes required after a site is initiated.
   Protocol #	Select the protocol from the list of existing protocols in the Pick Protocol dialog box.
   Region	Select the region name if regions are required for the protocol.
   Parent Site	Read-Only field. Populated only for satellite sites, this field indicates the name of the parent site to which the satellite site belongs.
   Status	Select the status of the site, for example, Planned, Initiated, Enrolling, and Closed. A preconfigured state model allows for a structured state transition.
   PI Last Name	Select the last name of the principal investigator for the site. To change the principle investigator for the site, you select a different contact in this field. For more information about adding other contacts to the site, see Associating Sites with Contacts. When you click the select button in this field, the Pick Contacts dialog box appears. After you select an account for the site, click the Affiliated Contacts button in this dialog box to view only those contacts who are affiliated with the account for the 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.
   Team	Select the team members for the site. The Primary field is populated for the site record creator, and only the team manager can change this field through the My Team’s Sites view. Resource management is a manager’s responsibility. For more information, see Step 3.
   No Subject Info	Select this field to indicate that no subject information is available for a site. Only summary information about subject enrollment is available for such a 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.
   Versions	Select the version of the subject visit template for the site. For more information, see Step 4.
   Currency Code	Select the currency that is used to display the payments, costs, and budgets for the site.
   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.
   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.

3. To add team members to the site, 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 Rollup.

      If the Regions Required field is selected for the protocol record, then multi-selected team members are added to the region and protocol to which the site belongs.

   3. Click OK.

4. Click the select button in the Versions field and complete the following steps:

   1. Select the version of the subject visit template to use at the site.

      Only the template versions related to your protocol are available for selection.

   2. Enter a date in IRB Approval Date field for the selected version.

      You cannot activate the template version without the IRB (institutional review board) approval date.

   3. Select the Active field to make the selected version the active version at the 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.

   4. Click OK

5. (Optional) Drill down on the site number field, and 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.