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 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
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.

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 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.

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.

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

Navigate to the Site Management screen, then the Protocol Site List view.
In the Protocol Site Visits list, select My Sites in the visibility filter.

All site visits that you own appear.
In the Protocol Site list, drill down on the Site Number field of the site under which you want to create the satellite site.
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.

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 described 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.).

Drill down on the Satellite Site Number field to complete more fields as required.

Some data is inherited from the parent site and cannot be changed. Some fields are described 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.

(Optional) 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 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.

Assign subject visits to the satellite site as follows:

Navigate to the Subjects view.
Create a new Subject record and complete the necessary fields.
Drill down on the Screening # field.

Create a new Visit Plan record and complete the necessary fields.

Some fields are described 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.

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".

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.
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.