b. Protocol Related Events

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Last updated: Jun 21, 2023 by Sonya Izadi
7 min read

TABLE OF CONTENTS


Protocol Related Events

The protocol related tab identifies all the events that relate to the operation of the protocol as a whole (IRB fees, Advertising fees, and Pharmacy fees). These can include fees that are incurred even without a single subject accrued.

Protocol Items can be configured as:

  • One-time charges   -OR-
  • Variable events that recur (such as Quarterly Pharmacy Fees). You can add variable events to multiple invoices.

Adding Protocol Related Events

*These items can only be set up once the Protocol Parameters tab has been updated, but are not dependent on a protocol calendar; they can be added to protocols with no calendar or an unreleased calendar.

  1. From the Financials Console select the left horizontal Protocol Related tab

  2. Before you have defined any events, the Protocol Related tab displays the message "No information found."

  3. Click Update and there will be two ways to add protocol-related events:

    1. Select them directly from the Charge Master

      1. Click the Select button.
      2. A browse results pop-up window will appear where you can search for the Event Description
        1. Begin typing an Event Description in the Find-As-You-Type drop down field
        2. Select the appropriate event when it appears in the list by clicking on it.  Events must first be entered into the Charge Master within OnCore before they are available here. 
        3. The events in the Protocol Charge Master are intentionally kept broad
          1. OST does not add new Protocol Charge Master events if there is one on the list that can be used for your protocol
          2. The Comments field to the right of the Event Description can be used to further define the protocol's Charge Master event 
          3. The "Other" Charge Master event can be used to add items that are not likely to occur across many studies.  
        4. Click the Add hyperlink

    2. Copy them from another protocol

      1. The events will correspond with the Charge Master version associated with the destination protocol, rather than the protocol you are copying from.

      2. In the Copy From Protocol field, enter the source protocol, select from the drop-down list and click Show Events.

      3. The Protocol Related Events window appears, listing the protocol-related events that have been defined for the source protocol. You can select all events, or only those that apply to your protocol, then click Copy Events.
  4. The events that you add will now appear on the Protocol Related tab.
  5. After the Protocol Related Events are added, the screen should show a list of all of the events you just added with a column for Comments and columns for Negotiated Price, Variable?, and Indirect? options
    1. Enter Comments if applicable
      1. Comments will show up on the Financial Events tab if the CRA Console trigger is used, so use as needed to provide further details beyond the Event Description.
      2. Comments show up on the sponsor invoice so only include comments that you would like the sponsor to see
    2. Enter Negotiated costs to the sponsor for each event
    3. Select the Variable? check box if the event is recurring and will need to be invoiced multiple times. If this box is left unchecked, the event can only be invoiced once during the life of the study.
  6. Once you have added all of the Protocol Related Events, proceed to the subsequent section to add the Protocol Event Details and fill in more details and parameters about each event you added

Protocol Event Details

Clicking the Event Description link opens the Protocol Event Details page.

  • Cost: Shows the dollar amount for the negotiated costs.  WashU does not use the Retail or Research costs.
  • Sponsor: This section is used if multiple sponsors have been associated with the protocol. While multiple sponsors can be invoiced for the same protocol event, the amount each sponsor should be charged for the event is indicated here. By default, the entire charge amount is allotted to the default sponsor indicated on the Parameters tab. You can use the Negotiated Cost fields to allocate the correct amount to each sponsor.  If the Protocol Charge amount as seen from the Protocol Related tab does not equal the sum of the sponsor costs as shown in the Protocol Event Details page above, an error message appears, and the amount can't be saved.
  • Trigger: Event Triggers are rules that have to be satisfied before the event can be added to an invoice. For guidance, see the Center for Clinical Studies' list of recommended Protocol-Related Event Triggers. Changes can be made to the protocol event trigger until the event is invoiced. Once invoiced, the trigger can only be made inactive, which will prevent the event from populating any more invoiceable items.  Protocol-Related Events are not required to have a trigger assigned.  Those Protocol-Related Events that are not assigned a trigger will have to be manually marked occurred in the Protocol Events tab.
    1. Select the Trigger Type from the drop down menu
      1. IRB Review Trigger: When IRB Review is selected, all IRB Review Reasons (ex: Change Review, Consent form) and IRB Review Types (ex: Expedited, Full) are listed. Select one or more of the applicable reasons and types. An IRB review with the specified reason and type will cause the associated protocol-related event to be invoiceable. 
        1. The Review Date on the IRB review must be populated in order to trigger the invoiceable item.
        2. When an IRB review with a reason matching a triggering event is created with a review date set, the Invoiceable Items tab is populated with the associated events. 
        3. Once a review has been invoiced, it can no longer be deleted from the PC Console > Reviews > IRB tab.
      2. IRB Study Closure Trigger:  An IRB review with the Review Reason of Closure will cause the associated protocol-related event to be invoiceable. 
        1. If an event associated with the IRB Study Closure status has been invoiced, the status can't be undone. 
        2. Changes can be made to the protocol event trigger until the event is invoiced. Once invoiced, the trigger can only be made inactive, which will prevent the event from resulting in any further invoiceable items.
      3. CRA Console Trigger: Events with the CRA Console trigger type set to active are available for selection in the CRA Console on the Financial Events tab, allowing subject staff to submit the event for invoicing. See our CRA Console Event Trigger Tip Sheet for more details.
        1. After an event is submitted on the CRA Console > Financial Events tab, it appears on the Financials Console > Invoiceable Items tab in the Protocol Items section with a triggering event of CRA Console. 
        2. If the trigger is set to inactive for an event, that event is no longer available for selection in CRA Console > Financial Events. However, any previously triggered events still appear in Financials Console > Invoiceable Items.
      4. Date Based Trigger: If you select the Date Based trigger, protocol-related events will be created on a recurring basis, starting with an initial start date and lasting indefinitely (or until a specified ending date or event). Each occurrence will create an invoiceable item in Financials Console > Invoiceable Items. Invoiceable items are created daily (1AM) by the Financial Date Based Trigger Job according to the schedule set in the Trigger window.  To set a date-based trigger:
        1. Enter the trigger start date. If the Starts On date is set in the past, up to 30 past occurrences will be created when you click Save. If there are more than 30 past occurrences, no occurrences are created until the Financial Date Based Trigger Job mentioned above next runs.
        2. Select the type of occurrence and how often it will happen. Occurrences will include the initial Starts On date. If the number of occurrences is set to 1, then the entry in the Starts On date will be the only triggering event.
        3. If the trigger has an ending, select the type and whether the ending should take place after a number of occurrences or on a specific date. The Ends After Occurrences field will accept up to 999 occurrences (including the entered date).
        4. If the Active setting is set to No, no events will be created. Even if the Active setting is later set to Yes, events will be created only from that point forward. Past events won’t be created
    2. Make sure the Active field is set to Yes
    3. If you have already set up a trigger and no longer want to use it, click the Edit button and set the Active field to No that corresponds with the trigger you would like to deactivate. Do NOT delete the trigger!

    4. Click Close once you have entered all the protocol event details and you will be brought back to the Protocol Related tab

Definitions

  • Event Code: A view-only field that is pulled directly from the Charge Master.

  • Additional ID: A view-only field that is pulled directly from the Charge Master.

  • Event Description: The name of the event. This view-only field is pulled directly from the Charge Master. Clicking the Event Description link opens the Protocol Event Details window.

  • Comments: This free-text field allows you to enter an additional event description (up to 1000 characters) that will appear along with the Event Description entry in other areas of OnCore.

  • Retail, Research, and Negotiated Charge: 

    • WashU does not house costs of Events in our Charge Master, so the Retail and Research fields will not be used.

    • The cost of the event will only need to be entered in the the Negotiated column once it is determined.
  • Variable: Allows an event to be invoiced for multiple times. Allows allows for multiple entries of the event in the CRA Console. 

  • Inflation: This is not used by WashU.

  • Indirect: This is not used by WashU.

  • Delete: This column allows you to select and delete events. Note that you can't delete events that are on an invoice or that have an active trigger.

Need more help? Contact the OnCore Support Team: oncore@wustl.edu