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TABLE OF CONTENTS

Protocol Related Events

The protocol related tab identifies all the events that relate to a protocol at an institution level (IRB fees, Advertising fees, and Pharmacy fees). These items can only be set up once the Parameters tab has been updated.

  1. From the Financials Console you can select from the allowable events list that pertain to the protocol
  2. If a protocol event is recurring (such as Quarterly Pharmacy Fees), it can be marked as Variable, allowing such an event to be invoiced multiple times
  3. From the Financials Console select the left horizontal Protocol Related tab
  4. Click the Select button
    1. If you can't see the "Select" button, click the Update button on the right side of the screen. 
    2. If you don't have the Update button either, you have not yet set up the Parameters tab.
  5. 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. 
      1. 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.  (An exception is made for events that need a CRA Trigger, since a more descriptive event name will be needed for the CRA to log the event).
    3. Click the Add hyperlink

  6. 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: 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.
  7. 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. 

                    

Event Triggers

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 resulting in any further invoiceable items:

  1. Select the hyperlink for an Event Description
  2. The Protocol Event Details page will open
    1. Select the Trigger Type from the drop down menu
    2. Select the Review Reason from the list provided (if applicable)
    3. Select the Review Type(s) (if applicable)
    4. Make sure the Active field is set to Yes
    5. 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!
    6. Click Close once you have entered all the protocol event details and you will be brought back to the Protocol Related tab


  3. If the event can occur more than one time, set the event to Variable (screenshot below)




Definitions

  • 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. 
    • The Review Date on the IRB review must be populated in order to trigger the invoiceable item. 
    • 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. 
    • Once a review has been invoiced, it can no longer be deleted from the PC Console > Reviews > IRB tab.

  • IRB Study Closure Trigger:  An IRB review with the Review Reason of Closure will cause the associated protocol-related event to be invoiceable. 
    • If an event associated with the IRB Study Closure status has been invoiced, the status can't be undone. 
    • 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.

  • 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.
    • 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. 
    • 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.

  • Variable: Allows an event to be invoiced for multiple times. Allows allows for multiple entries of the event in the CRA Console.