Siebel Clinical Trial Management System Guide > Setting Up Clinical Trials >

Creating Sites for Clinical Trials

The site is the group at an account, headed by a principal investigator, who carries out 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

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 described in the following table.

   Field	Comments
   Account	The institution where the protocol is to be carried out.
   Currency Code	The currency that is used to display the payments, costs, and budgets for the site.
   Exchange Date	The date that determines the exchange rate of the currency used. By default, the exchange date for the site is the date the site is created. This date can be changed in response to changes in currency rates. However, changes made 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.
   Last Completed Visit Date	Select this field to use the last completed clinical visit date 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.
   No Subject Info	Select this field when there is no subject information available for a site. Only summary information about subject enrollment is available for such a site.
   PI Last Name	Last name of the principal investigator. If an account has already been specified for the site, then click the Affiliated Contacts button in the Pick Contacts dialog box to view only those contacts who are affiliated with the account.
   Protocol #	Select from list of existing protocols in the Pick Protocol dialog box.
   Region	If regions are required for this protocol, then enter a region name.
   Site #	The number that is to be assigned 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 has been initiated.
   Status	Planned, Initiated, Enrolling, and Closed. A state model is preconfigured to make sure structured state transition.
   Team	The Primary field is populated for the creator of the site record, and can be changed only by the manager of the team through the My Team's Sites view. It is recommended that resource management is a manager's responsibility. For more information, see Step 3.
   Versions	For more information, see Step 4.
   Withholding Amount	The amount of the total payment to be withheld from the investigators until the trial is complete. The default value is that of the region or protocol, but can be overwritten at the site level.
   Withholding %	The percentage of the total payment to be withheld from the investigators until the trial is complete. The default value can be set at the region or protocol level, but can be overwritten at the site level.

3. To enter team members, click the select button in the Team field, select a team member in the Team picklist and click OK.

   If you multi-select team members and click Position Rollup, and if the Regions Required field is selected, then the team members are added to the region that the site belongs to and are added to the protocol to which the site belongs.

4. Click the select button in the Versions field and complete the following steps:
   1. Select the version for the subject visit template to be used at the site.

      The versions are filtered to display only the templates related to your protocol.

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

      The template version cannot be activated 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.

      NOTE:  The IRB Approval Date must be entered before the template can be activated.

5. Create records for the principal investigator and other key site personnel.

   For information, see Creating and Updating Sites, Contacts, and Accounts.

6. (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.
   Contract Amount	Lists the sum of all contract amounts for the site. This field is read-only. For more information, see Associating Contracts with Sites.
   # Early Terminated	The number of subjects who have terminated the study before it has been completed.
   Earned To Date	The amount of money earned to date by the investigators.
   First Subject Enrolled	The date that the first subject was enrolled to the study. (This field is automatically rolled-up from the subject data.)
   Last Subject Off Study	The date that the last of the subjects has completed the study. (This field is automatically rolled-up from the subject data.)
   Paid To Date	The amount of money paid to date to the investigators.
   # Screen Failure	Number of subjects that have failed the screening.
   Primary Site Address	This field sets the primary site location for the study in Siebel Clinical, and is populated by the Pick Location applet. The Pick Location applet displays all addresses that have been defined for the site. This field is required for integration with Oracle Clinical, and is used to populate the site address when the site is created in Oracle Clinical.
   Activate for Synchronization	This field is required for integration with Oracle Clinical. When this field is checked, it triggers the sending of a new integration object for the protocol site 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.

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

When a member is added to the 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 who has worked 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

1. Navigate to the Site Management screen, then the Protocol Site List view.
2. 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.
3. Navigate to the Team History view.
4. 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 a member is removed 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 already 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 was 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 both these particular sites as well as all other sites within this protocol that include this user as a team member.