Setting Up Studies for Site Payments

Vault Payments allows you to track payable items for site payments within CTMS Vaults. Managing payment requests within Vault streamlines reimbursement and frees study personnel to manage other critical aspects of a trial.

Payment specialists define Fees for sites based on the Clinical Trial Agreement. As Subjects attend Subject Visits and undergo Procedures throughout the trial, Vault automatically generates Payable Item records based on the defined Fees and supports the manual generation of Payable Item records when eligible payable events are created or updated. Payment specialists can then group Payable Items under a Payment Request and generate payment letters. The Payment Request can be routed for approval and processing by your organization’s Accounts Payable systems.

Study Design Configuration

Visit Definitions & Study Groups

Visit Definitions define a standard set of Subject Visits that subjects can attend during the course of that Study, while Study Groups define a standard set of groups for that study. After creating these records, you can create Subject Visit records to track visits a subject completes over the course of the trial, as well as associate a Study Group record to the subject.

Repeating Visits

In Vault EDC, users can create Visit Groups to manage a Visit or set of Visits. For studies where the same Visit Group is making repeat visits, you can create Visit Group Definition records to define groups. You can create these records in Business Admin, where you must also select the relevant Study from a picklist, or via the Visit Definitions section of a Study record. Creating Visit Group Definitions and related records allows for defining more specific Fees.

In addition to a Name, you must specify the Expected Repeats value. The Max Repeats field is optional; Vault uses this field for EDC connections and isn’t used otherwise.

If your Vault receives repeating visit information from EDC Vaults, it generates Payable Items based on the shared Visit Definition, Visit Group, and Repeat Instance Sequence for each Subject Visit

For each Visit Group Definition, you can define Repeat Instance Identifiers. Specify a Name and Instance Sequence for each.

Once Visit Groups and Repeat Instance Sequences are created, you can define Fees for each recurrence.

Procedure Definitions

Procedure Definitions outline a standard set of Procedures that subjects will undergo over the course of the trial, for example, biopsies or CT scans. Create Procedure Definition records from the Procedure Definitions section on a Study record’s details page.

If your Vault utilizes the CDMS & Clinical Operations Vault Connection, you can configure your Vault to receive updates made to Procedure records in a connected EDC Vault. Note that for Vault to transfer Procedures, the Names of the Procedure Definitions must be identical in both Vaults. See Configuring the CDMS & Clinical Operations Vault Connection for details.

Creating Procedures

After creating Subject Visits, you can create Procedure records related to a Subject Visit. For example, you could create a Procedure record for a CT scan performed on a subject during a Subject Visit. Create Procedures from the Procedures section of a Subject Visit record’s details page.

If configured, your Vault may receive new Procedure records and updates to existing Procedure records from a connected CDMS EDC Vault.

Site Fee Definitions

Site Fee Definitions outline the items eligible for reimbursement that are not related to a subject. For example, you could define Site Fees for a Start-Up Fee and Initial IRB Approval. Create Site Fee Definition records from the Site Fee Definitions section on a Study record’s details page.

Payee Setup

Payee records represent the recipients of reimbursements. Payees are available from the Study Organizations associated with the site. When defining Payees for a site, you can select the Organization, Location, and whether the organization will serve as the primary payee. For example, you could identify that the clinical site organization and a separate local laboratory will be reimbursed for some subject-related payments.

When Vault generates Payable Items, it checks these records in this order:

1. Any Payee Overrides defined.
2. The primary payee of the Fee Schedule.
3. The primary payee of the Site.

Vault assigns any Payees it finds going through the list, creating one Payable Item record for each payee defined by an override or set as a primary payee. Should none be defined, the Payee field remains blank.

Payee Override

In some cases, there may be multiple payees defined for a given fee, or the desired payee may be different than the primary. You can address these scenarios using Payee Overrides.

To enter Payee Overrides for a fee:

1. Navigate to a Fee record and select Yes on the Payee Override field. Vault will display a Payee Override section.
2. From the Payee Override section, click Create.
3. Select the Payee and enter the amount of the override.

Fee-Related Objects Setup

Fee Schedules

Fee Schedules are a collection of fees negotiated with a site. You can set the Study Organization for a Fee Schedule to divide fees between various organizations at a site when there are separate contracts for main hospitals, labs, or pharmacies, for example. This allows you to manage entire Fee Schedules for multiple Payees at the same site, each with their own effective dates. You can use Payee Override functionality for further flexibility.

Create Fee Schedule records from the Fee Schedules section on a Site record’s details page. You can create Fee Schedules from an existing Fee Schedule or approved Fee Schedule Template. The Create Fee Schedule action allows users to pick an existing Fee Schedule Template to copy or to create an entirely new Fee Schedule.

When you copy an existing Fee Schedule, Vault copies all related fees from the Fee Schedule. All the records Vault creates in copying the Fee Schedule are in Initial state. By default, the list only includes Fee Schedules at the Site. You can, however, choose to include Fee Schedules from other Sites in the Study.

You can also update an existing Fee Schedule with Fees from an approved Fee Template by using the Copy Fees from Template action. When you run this action, Vault creates the Fees from the selected Fee Schedule Template and associates them with your Fee Schedule.

A fee schedule must be approved in order for Payable Items to generate. You can create and approve multiple Fee Schedules, with the following limitations:

• The end date of one Fee Schedule cannot overlap with the start date of another Fee Schedule. For example, you cannot create a Fee Schedule with a start date of Dec 25 2020 if a Fee Schedule exists with an end date of Dec 31 2020.
• No gaps can exist between Fee Schedule start and end dates. For example, you can only create a second Fee Schedule with a start date of Dec 25 2020 if a Fee Schedule exists with an end date of Dec 24 2020.
• Only one Fee Schedule can have a blank start date and only one Fee Schedule can have a blank end date.

Fee Schedule Templates

You can use a Fee Schedule Template to define a set of Fees at the Study or Study Country level that Vault can use to default Fees for a given site. Once Vault defaults Fees from a template, you can update them to align with any site-specific negotiations.

Create Fee Schedule Template records from the Fee Schedule Template section on a Study record’s details page.

You can also create a new Fee Schedule Template by copying an existing Fee Schedule Template on the Study record. This option is not available if no Fee Schedule Templates exist for a Study.

Fees

You define Fees as part of a site’s Fee Schedule. Fee information is generally captured within the Clinical Trial Agreement and outlines the various amounts a site will be reimbursed for different activities. Vault includes three (3) Fee types:

• Visit Fees: Fees related to a given Subject Visit, for example, a baseline visit.
• Procedure Fees: Fees related to a given Procedure, for example, a blood draw.
• Site Fees: Fees not related to subject activities, for example, IRB Approval.

To create Fee records:

1. Navigate to the Fees section within your Fee Schedule record’s details page.
2. Select a Fee Type.
3. Select a Visit, Procedure, or Site, depending on the Fee Type you chose. The Visit or Procedure you chose must already be defined.
4. In the Payment Rules section, select all statuses for which a Payable Item should be created.
5. Optional: Enter payment rules for the fee.
6. Optional: Select a Budget Category to track this Fee against the study budget.
7. Optional: Set Include Overhead to Yes and enter an Overhead Percentage to designate a portion of the fee as overhead.
8. Optional: Set Include Holdback to Yes and enter an Holdback Percentage to hold back that portion of the payment until it is marked for payment.
9. Optional: Set SDV Required to Yes if Site Data Verification is required for a Site Visit.
10. Enter the Amount the site will be reimbursed for this fee type.
11. Click Save or Save + Create to create more Fee records.

Fee Criteria

Status

Subject Visits, Procedures, or Site Fees can be in different statuses throughout clinical trial conduct, such as Planned, Submitted, and Completed.

The Statuses that you select when creating a Fee defines when Vault creates payable items during clinical trial conduct. For example, if you selected a Submitted status for a Fee of type Visit, when the Subject Visit record enters the Submitted state, Vault automatically creates Payable Item records for the Fee.

You can select multiple statuses if necessary. Vault will create Payable Items when the visit, site fee, or procedure reaches any of the selected statuses. Note that Vault will only create one set of Payable Items for each Fee.

Subject and SDV Status

You can also set criteria for Fees based on Subject or SDV Status:

• Subject Status: When set for a Visit or Procedure Fee, this option generates a Payable Item when the Subject Status on a Subject Visit matches the Status chosen.
• SDV Complete: Set this to Yes to generate a Payable Item once the SDV Complete field on a Site Visit record is also Yes.
• SDV Complete Only when SDV Required: Set this to Yes to generate a Payable Item when both SDV Required is True and SDV Complete is True on the Visit record. If SDV Required is False on the Visit, the Payable Item will generate.

Payment Options and Rules

Some studies have additional requirements. For example, it may be negotiated that a site will not be reimbursed for more than a certain number of screen failures, or you may need to provide an advance payment to the site. Use these options on your Site Fee record to accommodate these requirements:

• Include Holdback indicates that when a payable event meets the Fee criteria, two Payable Items will be generated.
• Include Overhead indicates that the Base Amount field will be entered and the Total Amount field will update based on the Fee’s Overhead Percentage.
• A Maximum Count allows you to limit the total number of payable items that Vault will generate for a site.
• A Rate limits the number of payable items Vault will generate based on the number of subjects in a particular Rate Metric, for example, the number of subjects in the Enrolled status.
• You can elect to pay a site in advance by setting Site Advance to Yes. Doing so automatically creates debit and credit Payable Items for the amount, and as the site does incremental work it will accrue Payable Items to offset the Site Advance and then initiate ongoing Payments.

Recurring Visit Fees

In some cases, sites may have negotiated different amounts for visit activities depending on a subject’s assigned Visit Group and the Repeat Instance Sequence. For example, a Week 1 Visit may be reimbursed $300 per subject for Treatment Group Cycle 1 and $400 per subject for Treatment Group Cycle 2.

Based on the Visit Group and Repeat Instance Sequence selected for a fee, Vault will generate Week 1 payable items in the amount of $300 if the subject is in Treatment Group Cycle 1 and $400 if the subject is in Treatment Group Cycle 2.

Fees with Study Groups

In some cases, sites may have negotiated different amounts for visit activities depending on a subject’s assigned Study Group. For example, a Week 1 Visit may be reimbursed in the amount of $300 for a subject on Study Group A, and $400 for a subject on Study Group B.

Based on the Study Group selected for a fee, Vault will generate payable items in the amount of $300 if the subject is on Study Group A and $400 if the subject is on Study Group B.

Additional Fees for Study Expenses

Build a library of Additional Fees in your Vault, which you can use to create Payable Items at the study, study country, and study site levels. You can then use these fees to track ad hoc and vendor payments that fall outside of pre-defined fee schedules. For example, you can utilize Additional Fees to reimburse IRBs for a study-level ethics review, CROs for managing study conduct in a country, and sites for equipment maintenance expenses.

Creating Additional Fees

Navigate to Admin > Business Admin > Fees or a custom tab to Create Additional Fee types of Fee records. You can define one or more Payment Levels for each fee.

Setting Up Vendors for Payments

Adding Vendors to Global Directory

Vendors must be active in the Global Directory for you to be able to associate them with study-specific Payable Items for Additional Fees. To add a new Organization:

1. Navigate to Global Directory > Organizations
2. Click on Create to create a new Organization record
3. Select an Organization Type and click Continue.
4. Enter the details and click Save.

Adding Vendors to a Study

Add active Organizations to the Study Organization section of a Study record to track vendor participation in a study and make them eligible to receive payments. Add the vendor with the appropriate level of detail

Adding Additional Fees to a Study or Site

Add Additional Fees in the Payable Items section of Study, Study Country, or Study Site records.

Budget Tracking Setup

You can also setup your Vault to track budget categories for study budgets. See Configuring for Study Budget Tracking for more details.

Related Permissions

The following permissions control your ability to setup studies and payment components for Vault Payments:

Type	Permission Label	Controls
Security Profile	Objects: Visit Definitions: Create, Edit	Ability to create and edit Visit Definition records.
Security Profile	Objects: Subject Visit: Create, Edit	Ability to create and edit Subject Visit records.
Security Profile	Objects: Study Group: Create, Edit	Ability to create and edit Study Group records.
Security Profile	Objects: Procedure: Create, Edit	Ability to create and edit Procedure records.
Security Profile	Objects: Procedure Definition: Create, Edit	Ability to create and edit Procedure Definition records.
Security Profile	Objects: Site Fee: Create, Eidt	Ability to create and edit Site Fee records.
Security Profile	Objects: Fee Schedule: Create, Edit	Ability to create and edit Fee Schedule records.
Security Profile	Objects: Fee: Create, Edit	Ability to create and edit Fee records.
Security Profile	Objects: Fee Schedule Template: Create, Edit	Ability to create and edit Fee Schedule Template records.
Security Profile	Objects: Budget Categories: Create, Edit	Ability to create and edit Budget Category records.