Configuring Vault Payments for Site Payments

Vault Payments allows you to track all clinical trial expenses within a single application, including payable items for clinical sites, ad hoc expenses, study budgets, and vendor payments to CROs and IRBs. This provides your organization with a complete picture of clinical trial expenses within your Vault.

You must complete these configuration steps before you can setup studies and payment components for payments.

Study Configuration Overview

• Contact Veeva Support to add Vault Payments to your CTMS Vault.
• Update permission sets to grant users access to the payments-related objects and navigation tabs.
• Add the fee-related objects to the Study or Site object page layouts.
• Add the Generate Payable Items action to the Study, Study Country, Study Site, or Fee Schedule objects.
• Optional: Add the Update Holdback Item Based on Fee user action to the Study, Study Country, or Study Site objects if you wish to use Holdbacks.
• Optional: Configure the Enable Automated Adjustments for Payments setting.
• Optional: Configure objects to track additional fees for study expenses.
• Optional: Configure study budget tracking.
• Optional: Add the Approve and Update Related Fee Schedules user action to applicable Fee Schedule lifecycle states, workflows, or as a bulk action.

Supporting Components

Vault Payments relies on a set of objects that represent the design of different fees, along with a set of objects that support actual instances of fees. Adding Vault Payments to your Vault enables the following objects and fields:

Design Objects

• Visit Definition: Defines the types of subject visits that may occur over the course of a clinical trial, for example, Screening, Baseline, Week 1, Week 2, and End of Study visits. This object is only available on CTMS Vaults.
• Procedure Definition: Defines the different types of procedures subjects may complete over the course of a clinical trial, for example, a biopsy or a CT scan.
• Site Fee Definition: Sites are reimbursed for site-related items, such as IRB approval, equipment storage, and administrative activities.
• Fee Schedule Templates: Fee Schedule Templates allow you to pre-define commonly used Fees available for use at multiple sites. Fee Schedule Templates are created and managed at the Study or Study Country level. Once approved, Fee Schedule Templates allow for easily populating a Fee Schedule with the appropriate fee set for a study.
• Fee Templates: Fee Templates allow you to specify the Visits, Procedures, and Site Fees that will be used in the Study or Study Country. They can include details such as the expected amount and valid statuses for payment.
• Payees: Organizations from the Global Directory must be associated with the Study and Study Site to be eligible to receive Payment Requests in Vault.

Fee-Related Objects

• Subject Visit: Stores instances of Subject Visits, for example, Screening, Baseline, and Week 1. This object is only available on CTMS Vaults.
• Procedure: Stores instances of Procedures for a Subject.
• Site Fee: Stores instances of Site Fees for a Site, such as IRB approval, equipment storage, and administrative activities.
• Fee Schedule: Stores a collection of Fees negotiated with a Site, along with start and end dates for the duration of the contract.
• Fee: Fees are associated with a site’s Fee Schedule. Fees can be one of three types: Visit, Procedure, and Site Fee. A Fee defines what a site should be reimbursed for and the amount.
• Payable Item: Stores instances of Payable Items. Vault generates Payable Items when a Subject Visit, Procedure, or Site Fee is updated to a status defined on the related Fee record.
• Payment Request: Stores Payment Requests. Users can associate a collection of Payable Items marked to Pay with a single Payment Request record and select information such as Payee, Payee Location, Check Number, and Check Dates.
• Payment Request Detail: Simple join object that stores the relationship of Payable Items to the Payment Request.

Configuring the Generate Payable Items Action

The Generate Payable Items action gives users the ability to manually generate payable items. In addition, if you have enabled automated payment adjustments, the action evaluates and adjusts Payable Items. It can be applied to Study, Study Country, Study Site, and Fee Schedule objects as a user action or as a system action within a workflow.

To add the Generate Payable Items action to the Study, Study Country, Study Site, or Fee Schedule object:

1. Navigate to Admin > Configuration > Objects > [Object] > Actions > Create.
2. Select Generate Payable Items from the Select Action picklist.
3. Click Continue.
4. Optional: Modify the details of the action.
5. Click Save.
6. Navigate to Configuration > Object Lifecycles > [Object Lifecycle].
7. Click on the object lifecycle state that requires the Generate Payable Items user action.
8. Click Edit in the User Actions section.
9. Click Create Rule and define the user action to Generate Payable Items.
10. Click Save.
11. Optional: Apply the Generate Payable Items user action to additional object lifecycle states.

To add the Generate Payable Items action to a workflow:

1. Navigate to Admin > Configuration > Object Workflows > [Object Workflow].
2. Configure the Workflow Steps to include the Generate Payable Items system action as needed.

Configuring Enable Automated Adjustments for Payments

If you wish to use Vault’s automated payment adjustment capabilities, you must enable the Automated Adjustments for Payments setting. If you set Enable Automated Adjustments for Payments to True, Vault automatically adjusts Payable Items when changes are made to Payable Activities and when you run the Generate Payable Items action. If you set Enable Automated Adjustments for Payments to False, Vault does not automatically adjust Payable Items when changes are made to Payable Activities or when you run the Generate Payable Items action.

You can change the Enable Automated Adjustments for Payments setting by navigating to Admin > Settings > Application Settings.

Configuring Additional Fees for Study Expenses

We recommend that you complete the following steps to allow users to create and track Additional Fees for Study Expenses:

• Add the Additional Fees type of Payable Items object to the Payments tab.
• Add a Payable Items related object section to the Organization, Study, and Study Country page layouts.
• Add a Payment Requests related object section to Study Site, Organization, Study, and Study Country page layouts.

Setting Up Studies for Vault Payments

Study managers must complete additional setup steps before Vault Payments can manage expenses, budgets, and payment requests. See Setting Up Studies for Vault Payments for more details.

Related Permissions

The following permissions control your ability to configure Vault Payments:

Type	Permission Label	Controls
Security Profile	Admin: Objects: Edit	Ability to edit object details and page layouts.
Security Profile	Admin: Object Lifecycles: Edit	Ability to configure object lifecycles.
Security Profile	Admin: Object Workflows: Edit	Ability to configure object workflows.
Security Profile	Admin: Permission Sets: Read, Create, Edit, Delete	Ability to configure Permission Sets.