8Setting Up and Making Clinical Payments

About Setting Up and Making Clinical Payments for Subject Activities

You set and adjust payments to investigators and sites at the following levels:

  • The financial administrator sets standard payment amounts through the subject visit template.

  • You set exceptions to standard payment amounts according to agreements that individual sites negotiate.

  • You can further adjust payments on a one-time only basis before you generate the payments.

Not all subject activities have payment amounts associated with them. For example, obtaining informed consent might be a subject activity for which you do not pay the site, but you pay a site for performing a blood test. Subject activities for which you pay the site are payment subject activities. (In the Siebel Clinical interface, the Payment Flag field indicates these activities.)

In addition to subject activities, you can pay sites for other activities that end users create at the site level, such as IRB (institutional review board) fees and equipment costs. End user can designate those activities as payable to the site with the Payment Flag field. For information about managing budgets at the protocol level, see Managing Clinical Projects.

You can use multiple currencies for a protocol. For more information about setting up currency conversions, see Siebel Applications Administration Guide.

You can set currencies and exchange rate dates at the following levels:

  • Protocol level. You associate a single currency code and exchange date with a protocol record. All payments you make to sites for the protocol are converted to and rolled up in the protocol currency.

  • Region level. If regions apply to the protocol, then set a currency code and exchange date for each region. All site payments you make in that region are converted to and rolled up in the region currency.

  • Site level. Set a currency code and exchange date for each site. When you use a subject visit template to create subject visits and activities, all payment activities are converted to the currency for the site on the exchange date for the site.

Scenario for Clinical Payments

This topic gives one example of how clinical payments might be used. You might use payments differently, depending on your business model.

Using the input from the clinical contract or grant negotiations group, the financial administrator sets up the standard payment amounts for procedures and tasks that the site performs. A major pain-point for clinical organizations is managing investigator payments. Often organizations pay investigators for activities that they do not complete, or for activities that they complete, but not to the satisfaction of the sponsor. By specifying a withholding amount and a withholding percentage, you can withhold payments from an investigator to make sure that all activities are complete. Investigators are motivated to complete all activities so that they receive full payment.

The CRAs (clinical research associates) set up the payment exceptions for sites where different payments are negotiated for subject activities. (In some organizations, the study manager performs this task instead of the CRA.)

As the sites carry out the procedures, the financial administrator verifies successful completion of the procedures, and generates payments for these activities. He generates a payment (minus the withholding amount or percentage) when an activity is complete. If all activities for a site are complete, then he pays the investigator the full amount for all activities, including the withholding amount or percentage.

Occasionally, the sponsor or CRO (clinical research organization) must make an additional payment to a site, and the payment is not directly associated with subject activities. These payments are unplanned payments. A reimbursement for an unscheduled visit is an example of an unplanned payment.

Note: As the clinical trial progresses, the sites complete the subject activities for which they are paid. Typically, personnel at the sites enter complete dates for subject activities using Siebel Site Portal. For more information about Siebel Site Portal, see Siebel Life Sciences Portals Guide.

Setting Up Standard Payment Amounts in Subject Visit Templates

You can set up payment amounts when you create the subject visit template. For more information, see About Subject Visit Templates.

Also, you can add payment amounts later by following the procedure in this topic. You can enter payments at the site level in any currency. All payment amounts at the site level are converted to the currency for the site and rolled up into the currency for the region. If a region is not applicable, then payment amounts at the site level are rolled up into the currency for the protocol.

Note: This task requires administrator privileges.

To set up standard payment amounts in the subject visit template

  1. Navigate to the Administration - Clinical screen, then the Visit Templates view.

  2. Select the subject visit template and template version for which you want to add payment amounts.

  3. For each visit and each activity for which to pay the sites:

    1. Select the Payment Flag field.

      If you do not select this field, then the activity does not appear in the Payment Activities view, and you cannot generate a payment.

    2. In the Payment Amount field, use the currency calculator to enter the amount and currency code.

Setting Payment Exceptions for Sites

The currency at the site might differ from the currency for the standard amount. Also, the paid amount to individual sites for a particular procedure can differ from the standard amount in the subject visit template. For more information, see Setting Up Standard Payment Amounts in Subject Visit Templates.

The procedure in this topic explains how to use payment exceptions to change the standard amount for a payment subject activity for an individual site. After you set the payment exception for an activity associated with the given site, visit, and template version, each time the activity is generated for a subject, the activity shows the site-specific amount.

Note: When a new subject visit template becomes active, set payment exceptions for the new template.

To set payment exceptions 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 set up payment exceptions.

  3. Navigate to the Payment Exceptions view.

  4. In the Payment Exceptions list, create a new record.

    The Payment Exceptions dialog box filters payment subject activities to show only those activities for the current protocol version. However, you can query from the set of all payment subject activities with the Payment Flag field selected across all versions and protocols. Consequently, you can set payment exceptions for activities in protocol version 2 and in protocol version 1, for example, if you expect the site to transition to the newer version in the near future.

  5. In the Payment Exceptions dialog box, select all activities for which you want to set payment exceptions, and click OK.

  6. In the Exception Amount fields, enter the new amounts to pay to this site for each activity.

    Note: The exception amount to pay at the site level might be in a different currency than the currency in the subject visit template or for the site. When you create subject activities at a site, the currency is converted to the currency for the site.

Splitting Payment Activities Between Multiple Payees

You can split payment activity between multiple contracts and payees. Each contract and payee combination for each payment activity split must be unique for the payment.

You define payment activity splits at the payment exceptions level in the Split Details applet. You can also define payment activity splits in the Split Details view for payments that do not have any payment exceptions. Scheduling a subject for the corresponding site applies the subject visit template, and creates a payment activity for each split payment in the Split Details applet.

To split a payment activity between multiple payees

  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 set up split payments.

  3. Navigate to the Payment Exceptions view.

  4. In the Payment Exceptions list, select the record for which you want to create split payments.

  5. Navigate to the Split Details list.

  6. Create a new record for each payment split and complete the necessary fields.

    Some fields are described in the following table.

    Field

    Comments

    Contract

    Select the payee contract from the list of contracts. The contract and payee combination for each payment split must be unique for the payment.

    Account

    Displays the primary account for the selected contract.

    Payee Last Name

    Select the payee last name from the list. The list displays all contacts for the primary account of the selected contract.

    Payee First Name

    Displays the payee first name.

    Split Percentage

    Type the split percentage for each payment split. The total split percentage for all of the payment splits must be one hundred percent.

    The split percentage is automatically calculated if you manually enter the amount in the Split Amount field.

    Split Amount

    Displays the split amount by using the split percentage of the total payment amount. You can also manually enter the amount.

  7. After you create all payment splits, verify that the Split Status (icon) in the Payment Exceptions view is activated (or green in color), which indicates that the total splits for the payment amount to one hundred percent.

Copying Details for Payment Splits

You can copy the details of a split payment activity to multiple payment activities. You copy payment activity splits at the payment exceptions level.

To copy details for a payment split

  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 copy split payment details.

  3. Navigate to the Payment Exceptions view.

  4. In the Payment Exceptions list, select the record that you want to copy.

  5. Click Apply Split to Other.

    The Payment Activities Select Applet appears.

  6. Select the payment activities to which you want to apply the split details, and click OK.

    The split details are created in the Split Details applet for all of the selected payment activities.

  7. Navigate to the Split Details applet, and make any required amendments.

Reversing Splits for Payment Activities

This topic describes how to reverse a payment activity split. The split details for each payment are deleted from the Split Details applet.

To reverse a split for a payment activity

  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 reverse payment activity splits.

  3. Navigate to the Payment Exceptions view.

  4. In the Payment Exceptions list, select the records that you want to reverse.

  5. Click Unsplit.

  6. Click OK to delete the split details for the selected payment activities.

    The split details for each selected payment activity are deleted from the Split Details applet.

Marking Subject Activities as Complete

Usually the site personnel use Siebel Site Portal to enter the date that subjects complete activities. However, a CRA (clinical research associate) can also perform this task using Siebel Clinical.

To mark subject activities as complete

  1. Navigate to the Subjects screen, then the Subjects List view.

  2. In the Subject list, drill down on the screening number field of the subject with complete activities.

  3. Navigate to the Visits view.

  4. In the Visit Plans list, select the visit that is complete, and click Complete Activities.

    The selected visit and all of its activities are marked as complete as follows:

    • The Completed field is selected.

    • The Completed Date field of all activities for the selected visit are populated with the same value in the Completed Date field of the parent visit.

    • The Status field is set to Done.

  5. If necessary, edit the fields for the visit in the Activities list.

Creating Payment Activities for Sites

This task describes how to create a payment activity record for a clinical site. This record includes the contract, account, and payee details.

To create a payment activity 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 payment activity.

  3. Navigate to the Payment Activities view.

  4. In the Payment Activities list, create a new record and complete the necessary fields.

    Some fields are described in the following table.

    Field

    Comments

    Payment

    Select this field to define the activity as a payment activity.

    Standard Amount

    Type the payment amount prior to any adjustment.

    Deviation Amount

    Type a value in this field to adjust the value in the Actual Amount field.

    Actual Amount

    Displays the actual amount to pay to the site. The actual amount is calculated as follows:

    Standard Amount plus Deviation Amount equals Actual Amount

    Contract

    Select the payee contract from the list of contracts.

    Account

    Displays the primary account for the selected contract.

    Payee Last Name

    Select the payee last name from the list. The list displays all primary accounts for the selected contract.

    Payee First Name

    Displays the payee first name.

Generating Payment Records for Sites

This topic describes how to generate payment records from payment activities. Payments are generated for each unique contract, account and payee combination for complete payment activities.

To generate a payment record 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 generate a payment.

  3. Navigate to the Payment Activities view.

  4. In the Payment Activities list, select the Completed field for each payment activity to use for generating the payment record.

  5. Click Generate Payment.

    The complete payments are removed from the Payment Activities list. Payment records for each unique contract, account and payee combination are generated in the Payments list.

Generating Payment Records for Sites Associated with Clinical Protocols and Regions

You can generate payment records for the sites that are associated with a clinical protocol and with a clinical region.

After you complete the payment generation task, the payment records can appear in the Payments view in the Protocol List view of the Protocols screen and in the Payments view in the Region List view of the Regions screen. Also, the payment records appear in the Payments view in the Protocol Site List view of the Site Management screen. Payment records appear in these Payments views only if, before you start the payment generation task, complete, unpaid payment activities exist in the Payment Activities view in the Protocol Site List view of the Site Management screen.

In the Payments view in the Protocol Site List view of the Site Management screen, you can change the field values in the generated payment records. Your changes are automatically reflected in the Payments view in the Protocol List view of the Protocols screen and in the Payments view in the Region List view of the Regions screen. You cannot manually change field values in the payment records in the Payments view in the Protocol List view of the Protocols screen and in the Payments view in the Region List view of the Regions screen.

    Generating Payment Records for Sites Associated with Clinical Protocols

    The Payments view of the Protocols screen is automatically populated with the existing payment records for the sites that are associated with the protocol. These payment records apply to the complete payment activities for those sites. In this view, you can generate payment records for complete, unpaid payment activities for the sites in the protocol.

    To generate payment records for sites associated with a clinical protocol

    1. Navigate to the Protocols screen, then the Protocol List view.

    2. In the Protocol list, drill down on the protocol number field of the protocol for which you want to generate payment records for sites.

    3. Navigate to the Payments view.

      If payment records exist in this view, then the selected payment record is irrelevant to this procedure.

    4. Click Generate Payment.

      A dialog box of site records applicable to the protocol appears. Your system administrator can set the Popup Visibility Type property to configure the records that appear in this dialog box. For more information about this property, see Applet Properties in Siebel Clinical.

    5. In the dialog box of site records applicable to the protocol, select the appropriate sites, and click OK.

      The complete payments are removed from the Payment Activities view in the Protocol Site List view of the Site Management screen. Payment records for each unique contract, account and payee combination are generated in the Payments view in the Protocol Site List view of the Site Management screen.

      You must again access the Payments view in the Protocol List view of the Protocols screen to view the generated payments. For the region that is associated with the selected sites, the generated payments also appear in the Payments view in the Region List view of the Regions screen.

    6. (Optional) To access a notification containing details about the payment generation, click Notification on the menu toobar.

      Your system administrator can set the WF properties to configure notifications for bulk payments. For more information about these properties, see Applet Properties in Siebel Clinical. For more information about using notifications, see Siebel Fundamentals Guide.

      Generating Payment Records for Sites Associated with Clinical Regions

      The Payments view of the Regions screen is automatically populated with the existing payment records for the sites that are associated with the region. These payment records apply to the complete payment activities for those sites. In this view, you can generate payment records for complete, unpaid payment activities for the sites in the region.

      To generate payment records for sites associated with a clinical region

      1. Navigate to the Regions screen, then the Region List view.

      2. In the Region list, drill down on the Region field of the region for which you want to generate payment records for sites.

      3. Navigate to the Payments view.

        If payment records exist in this view, then the selected payment record is irrelevant to this procedure.

      4. Click Generate Payment.

        A dialog box of site records applicable to the region appears. Your system administrator can set the Popup Visibility Type property to configure the records that appear in this dialog box. For more information about this property, see Applet Properties in Siebel Clinical.

      5. In the dialog box of site records applicable to the region, select the appropriate sites, and click OK.

        The complete payments are removed from the Payment Activities view in the Protocol Site List view of the Site Management screen. Payment records for each unique contract, account and payee combination are generated in the Payments view in the Protocol Site List view of the Site Management screen.

        You must again access the Payments view in the Region List view of the Regions screen to view the generated payments. For the protocol that is associated with the selected sites, the generated payments also appear in the Payments view in the Protocol List view of the Protocols screen.

      6. (Optional) To access a notification containing details about the payment generation, click Notification on the menu toobar.

        Your system administrator can set the WF properties to configure notifications for bulk payments. For more information about these properties, see Applet Properties in Siebel Clinical. For more information about using notifications, see Siebel Fundamentals Guide.

        Generating Payment Records for Unplanned Payment Activities

        You can create unplanned payments that are not associated with subject activities for clinical sites.

        To generate a payment record for an unplanned payment activity

        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 generate a payment.

        3. Navigate to the Payment Activities view.

        4. In the Payment Activities list, create a new record and complete the necessary fields.

          Some fields are described in the following table.

          Field

          Comments

          Completed

          Select this field. When you click the Generate Payment button, the process uses only payment activity records that are complete to generate payment records.

          Payment

          Select this field to define the activity as a payment activity.

          Standard Amount

          Type the payment amount prior to any adjustment. The actual amount is calculated as follows:

          Standard Amount plus Deviation Amount equals Actual Amount

        5. Click Generate Payment.

          The complete payments are removed from the Payment Activities list, and the payment record is created in the Payments list.

        6. To complete the payment, follow Step 6 to Step 8 in Adjusting Payment Amounts and Generating Payment Records for Sites.

        Adjusting Payment Amounts and Generating Payment Records for Sites

        Although payments are generally set for each site, occasionally the financial administrator might want to make additional adjustments to the paid amount for a given payment activity. For more information, see Setting Payment Exceptions for Sites.

        When the financial administrator finalizes the amounts, payments are generated for all complete payment subject activities in the currency for the site. Each payment record is given a unique identity number. You can later enter other information, such as check number, check date, and check amount, either manually or by importing the data from a back-office finance application.

        Note: This task requires administrator privileges.

        To adjust the payment amounts and generate payment records 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 generate payments.

        3. Navigate to the Payment Activities view.

          This view lists all scheduled payment subject activities for subjects associated with the site.

        4. (Optional) Adjust the Actual Amount to pay to the site by entering a value in the Deviation Amount field.

          Standard Amount plus Deviation Amount equals Actual Amount

        5. Select the Completed field, and click Generate Payment.

          The complete payments are removed from the Payment Activities list.

        6. Navigate to the Payments view.

          The payment generated in the previous step appears in the Payments list.

        7. Complete the fields in the payment record.

          Some fields are described in the following table.

          Field

          Comments

          Payment #

          Displays a unique number for the payment.

          Type

          Select the type of payment. For payment subject activities that are generated from the Generate Payment button, this field is populated with a value of Interim Payments.

          For payment subject activities that are generated from a back office application, this field is populated with a value of Initial Payments.

          Status

          Select the status of the payment record, for example, To be Processed, In Progress, Processed, and so on. A preconfigured state model allows for a structured state transition.

          Earned Amount

          Type the sum of the actual payment amounts for the complete payment activities.

          The sum of all values in the Earned Amount column equals the Earned to Date value of the site.

          Requested Amount

          Displays the requested amount of payment for the complete payment activities at this site. This field is calculated as follows:

          Requested Amount equals Earned Amount times [(100 less Withholding Percentage divided by 100) less Withholding Amount]

          Check Amount

          Type the amount of money for the check. This amount is usually, but does not have to be, the same as the earned amount.

          The sum of all values in the Check Amount fields for a site equals the Paid to Date value of the site.

          Check Date

          Select the issue date for the check.

          Check Number

          Type the number of the check.

          VAT Amount

          Type the value added tax for the site payment. The total VAT amount for all payments is rolled up to the region, protocol, and program levels, and appears in the VAT to Date field.

          Contract #

          Select the payee contract from the list of contracts.

          Account

          Displays the primary account for the contract that you select.

          You can also automatically load the information from a back-office finance application.

        8. (Optional) Drill down on the payment number field to view the payment activities associated with the payment.

        Generating Final Payments for Sites

        You can make final payments to sites when all payment activities are complete.

        Note: All prior final payments to sites must be complete and up to date before you can generate new final payments.

        To generate final payments 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 generate a payment.

        3. Navigate to the Payments view.

        4. Make sure that all Check Amount fields for past payments are up to date.

        5. In the Payments list, create a new record and complete the necessary fields.

          Some fields are described in the following table.

          Field

          Comments

          Type

          Select a value of Final Payment. When you set this field, the Requested Amount field for the final payment is automatically calculated as equal to the amount in the Earned to Date field for the site minus the amount in the Paid to Date field for the site.

          Status

          Displays a value of To Be Processed.

          Check Amount

          Type the amount of money for the check. This field is usually, but does not have to be, the same as the earned amount.

          Check Date

          Select the issue date for the check.

          Check Number

          Type the number of the check.

          VAT Amount

          Type the value added tax for the site payment. The total VAT amount for all payments is rolled up to the region, protocol, and program levels, and appears in the VAT to Date field.

          Contract #

          Select the payee contract from the list of contracts.

          Account

          Displays the primary account for the contract that you select.

          When you step-off and save the record, the Requested Amount field is automatically updated by subtracting the amount in the Paid to Date field for the site (that is, the amount in the Check Amount field) from the amount in the Earned to Date field for the site.

        Reverting Payment Records

        You can revert a payment record to modify the payment details. The Revert button is enabled when you select a single payment record with one of the following statuses:

        • In Progress

        • To Be Processed

        The Revert button is disabled for other statuses, and if you select multiple records.

        Your system administrator can modify the payment status values for which the Revert button is enabled by configuring the LS Clinical Enable Revert On Status user property in Siebel Tools. For more information about this user property, see User Properties for Business Components in Siebel Clinical.

        A reverted payment activity record is removed from the Payments view and returned to the Payment Activities view.

        To revert a payment record

        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 revert a payment.

        3. Navigate to the Payments view.

        4. Select the payment to revert.

        5. Click Revert.

          The payment records and split payment activities are updated as follows:

          • The reverted payment activity record is removed from the Payments view and returned to the Payment Activities view for further processing.

          • If the payment record consists of multiple payment activities, and if you revert only some of the payment activities, then the Earned Amount and Requested Amount fields are recalculated for the Payment record.

        Generating Oracle BI Publisher Reports for Clinical Payments

        You can integrate Siebel Clinical with Oracle Business Intelligence Publisher (BI Publisher) to generate reports. You can generate, view, and schedule preconfigured Oracle BI Publisher reports in Siebel Clinical. The preconfigured Protocol Payments report applies to clinical payments. For more information about using Siebel Reports and integrating with Oracle BI Publisher, see Siebel Reports Guide.

        To generate an Oracle BI Publisher report for Siebel clinical payments

        1. Navigate to the Protocols screen, then the Protocol List view.

        2. In the Protocol list, drill down on the protocol number field of the protocol for which you want to generate an Oracle BI Publisher report.

        3. Navigate to the Payments view.

        4. On the application toolbar, click Reports.

        5. In the Run Report pane, complete the appropriate fields.

          Some fields are described in the following table.

          Field

          Comments

          Report Name

          Select the Protocol Payments report.

          Output Type

          Select the output type for the report.

        6. Click Submit.

          The report runs.

        7. Click My Reports to navigate to the Reports view of the BI Publisher Reports screen.

          A record for the report appears in the Reports view. For information about viewing and printing the report, see Siebel Fundamentals Guide.