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TABLE OF CONTENTS

What are study Parameters?

The first step in creating a study budget is to set parameters in the Financials Console which affect the protocol's budget reports and sponsor invoices. Most of this information will be in your contract. Parameters used by WashU financial teams include:

  • Rate base (s)
  • Sponsor Withholding %
  • Billing and remitting contact information
  • Invoicing details for SAEs, OSRs (Outside Safety Reports/external SAEs (INDs)), and screen failures
  1. Hover over Financials Menu > Financials Console
  2. Enter protocol number into Select Protocol Field
    1. This is a filter as you type field so options will narrow the more characters you include
  3. Scroll to the bottom of the page and click "Update"

Budget Related Parameters

  1. Navigate to the first block in the financials console's main page to enter the Budget Related Parameters
  2. Select a Rate Base from the first drop down menu - this is an OnCore required field
    1. Options for WashU's rate bases are:
      1. FED-Federal
      2. FOUNDATION-Foundation
      3. IND-Industry
  3. Select the Default Sponsor from the second drop down menu and select the main financial sponsor for that protocol
  4. In the Sponsor Settings section, enter a Withholding % if the sponsor will withhold any payment until a later date
    1. Most sponsors withhold a percentage on just the subject milestones → select the box for the Subject Milestones to apply the withholding % to those items
    2. If your budget is negotiated to withhold for Protocol Related or Pass Thru items, select those boxes as well
  5. Indirect Rate % - Enter the indirect rate here.
  6. Enter No. of Cycles for Budget Calculations, if applicable. This is only applicable and required for protocol calendars created with open-ended segments
    • When a number is entered in this field for a given calendar version, the following areas are impacted:
      • Any possible milestone visits and/or pass through items will be created only up to the cycle number indicated
      • The Budget Summary and Budget Calendar reports will be calculated only up to the cycle number indicated
    • The Extending Visit notification
      • This notification is used to let the financial coordinator know that a subject has had a visit logged on this last cycle entered in the No. of Cycles for Budget Calculations field and that this number of cycles should be increased to allow additional milestones to be recorded. 
      • An email is sent to the Financial Coordinator listed on the protocol the morning after this visit was logged (overnight process).  
      • If you would like this notification to go to someone other than the Financial Coordinator listed on the protocol, this can be configured on a protocol by protocol basis. See Notifications Descriptions & Adding Custom Notifications for instructions.
    • When this number needs to be extended, the Financial Coordinator will create a New Unlocked Budget Version, extend the number in the Parameters No. of Cycles for Budget Calculations field, and add any additional Milestone and Pass Through items for these cycles.  Once the budget is released, these cycles will be available for invoicing on future subject visits for that calendar version.

7. Enter Comments, as applicable

What about these other boxes?

Currently, WashU is not using OnCore to support budget negotiations with sponsors and does not load applicable research costs in the charge master; therefore the following fields should remain blank and/or default numbers should not be changed:

  • Overhead Rate %
  • Inflation Multiplier - leave as 1.0
  • Settings for Application of Indirect- do not make changes to these default settings

Invoice Related Parameters

  1. Based on the CTA, enter Screening Failures to Invoice Ratio (Not Eligible: Enrolled), if applicable. 

    1. A screen failure occurs when a subject is marked as ineligible in the Subject Console. 

    2. Screen failures will appear in the Invoiceable Items tab if Screen Failed is set up as a milestone.

    3. The ratio x:y (Not Eligible:Eligible) indicates the sponsor can be billed for x number of subjects deemed ineligible, for every y number of eligible subjects. 

      1. Not Eligible: indicates the number of screen failures.

      2. Enrolled: indicates the number of subjects that must be considered "enrolled" in order for you to bill the sponsor for the number of screen failures indicated in the "Not Eligible" field.

      3. For example, a ratio of 1:4 means that you can invoice 1 screen failure after 4 subjects have been enrolled. 

    4. This ratio applies only after the value set in the Initial Invoiceable Screening Failures field is reached, and up until the Maximum Screening Failures is met.

  2. Based on the CTA enter Initial Invoiceable Screening Failures if applicable
    1. Indicates the number of screening failures that must occur before the Screening Failures Invoice Ratio applies. 
    2. When this field is left blank or set to 0, the Screening Failures Invoice Ratio applies immediately.
  3. Based on the CTA enter the Maximum Screening Failures if applicable
    1. Indicates the number of screen failures that will be available for invoicing. 
    2. In order for screening failures to display on the Invoiceable Items tab, you must have a value (other than 0) entered into Maximum Screening Failures. 
    3. Note that this setting can also be used on its own without the other values (Screening Failures Invoice Ratio, Enrollment Status, and Initial Invoiceable Screening Failures) being set.
  4. Enter No. of SAEs After Which Sponsor Will Be Invoiced
    1. Indicates the number of serious adverse events (SAEs) that must occur on the protocol prior to the sponsor receiving an invoice for SAEs. 
    2. The Invoiceable Items tab automatically begins listing the SAEs once the number meets and exceeds the limits indicated here, if SAEs are selected as milestones in the Milestones tab. 
    3. Enter 0 if you want the first SAE that occurs to be invoiced. 
    4. When this field is left blank, no SAEs are created as invoiceable items.
  5. Enter No. of OSRs After Which Sponsor Will Be Invoiced
    1. Indicates the number of Outside Safety Reports/external SAEs that must occur on the protocol for the sponsor to receive an invoice for OSRs. 

    2. The Invoiceable Items tab automatically begins listing the OSRs once the number meets and exceeds the limits indicated here, if OSRs are selected as milestones in the Milestones tab. 
      1. For example, when you enter 5 in this field, the fifth OSR is the first one added to the Invoiceable Items tab. 
    3. Enter 0 if you want the first OSR that occurs to be invoiced. 
    4. When this field is left blank, no OSRs are created as invoiceable items.

  6. Enter Milestone Invoiceable Visit Prerequisite to indicate when subject milestones can be invoiced
    1. These correspond to the date fields of the same name on the Subject Visit Update page within the Subject Console
    2. The Occurred Field corresponds to the visit status of "Occurred" within the Subject Visit Update page of the Subject Console
    3. If Occurred is chosen for this field, visits for this study can be invoiced as soon as they have occurred

Locked Fields

Please Note: Once an invoice is created, the following fields can never be updated. Please contact the OnCore Support Team if you need one of these fields changed- this will require support from our vendor.

  • Sponsor Settings:
    • Withholding
    • Protocol Related, Subject Milestones, and Pass Thru (to which Withholding applies)
  • Settings for Application of Indirect Rate
  • Invoice Related
    • Screening Failure Ratio
    • Enrollment Status
    • Initial Invoiceable Screening Failures

Remit To/Bill To

  1. Select Remit To or Bill To from the drop down.
    1. You can only have one Remit To address but you can have multiple Bill To addresses
    2. The Remit To address should match the contract
    3. The Bill To addresses should match the contract and can be marked Active or Inactive by checking/unchecking the box directly above the Add button
      1. This allows you to keep a record of all relevant addresses
      2. If you need to add the Sponsor # or PO #, add it to the Contact line.
  2. Once all information has been entered, click the Add button and the information will populate into the appropriate section below
  3. A Bill To sponsor is required to facilitate sponsor invoicing and payment reconciliation

Invoicing Reminder

  1. If you want OnCore to email a regular invoicing reminders, use the following fields:
    1. Notification Frequency (Months): Enter 3 here. WashU has a set notification frequency of every 3 months (Jan 1, Apr 1, June 1, Oct 1).  OnCore will ignore all other values.
    2. Number of Invoice reminders to send after study closure: Number of reminders sent once protocol has a completed status (Abandoned, Terminated, or IRB Study Closure).
    3. Notification Start Date: The date on which notifications are activated.  If you enter 4/15/2020 in here, for example, your first notification will occur on 6/1/2020.
    4. Notification Comments: Any other information you wish to add regarding the notifications.
  2. The invoicing reminder notification is an email that will go to the Financial Billing Contact and the Financial Coordinator listed on the protocol. There should only be one financial billing contact listed.
    1.  If you wish to modify who this notification goes to and what it says, see the Adding Notifications page.
    2. Here is the standard template for the Invoicing Reminder, which will be populated with the corresponding fields in OnCore: