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.

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

To create a site for clinical trial

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

In the Protocol Site list, create a new record and complete the necessary fields.

Some fields are described in the following table.

Field	Comments
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 list of existing protocols in the Pick Protocol dialog box.
Region	Select the region name if regions are required for the protocol.
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.

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.
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

(Optional) Drill down on the site number field, and navigate to the More Info view to add more information.

Some fields are described 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 Clinical. When this field is checked, a new integration object for the protocol site is sent to Oracle Clinical. The integration object creates the site in Oracle Clinical, 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 Clinical, and populates the site address when the site is created in Oracle Clinical.

About Automatically Assigning Team Members to a Site Using the Position Rollup Button

When you add a member to a team for a site (either manually or through the Position Rollup mechanism), a record is created in the Team History view, with the Start Date field set to the system date by default, and with a blank End Date field. To remove a team member from the protocol, see "About Removing Team Members From the Team of a Protocol".

Creating Assignment Team History for Sites

The Team History view allows you to administer and track team members who work on the site. It also provides details about the roles as well as the start and end dates.

To create assignment team history for a site

Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site list, drill down on the site number field of the site for which you want to create a new team assignment history.
Navigate to the Team History view.
In the Team History list, create a new record and complete the necessary fields.

About Removing Team Members From the Team of a Site

When you remove a member from the team of a site (either manually or through Position Rollup), the End Date field of the team member's record, if present, is updated with the system date. However, if the record is read-only, then the initial value in the End Date field is not updated. The Position Rollup mechanism automates the update of the End Date field of the assignment record as if it is manually removed from the team.

Note:

A prompt appears asking whether to remove the member from only the site or from all sites, regions, and protocols belonging to the site including these particular sites and all other sites within this protocol that include this user as a team member.