Milestones

After a budget has been negotiated or finalized, you can define the milestones for which the sponsor has agreed to pay. A milestone defines a specific protocol- or subject-related event that can be invoiced according to a study payment schedule. Tabs will appear across the top of the Milestones page indicating the subject/protocol calendar version and the latest budget version date in parentheses next to the version.  Invoiceable items are based on the milestones and pass thru procedures defined for a version of the calendar with which the visit was created. 

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1. In the Financials Console select the Milestones vertical tab

2. Click "Update" to set up invoicing milestones

3. Click "Select"

4. The screen that opens up will be the Protocol Events/Visits list which is divided into two parts:

   1. Subject Event Milestones represent specific events associated with subjects as they progress through a clinical trial from screening to trial completion. The following are the Subject Event Milestones that are provided by OnCore and the corresponding date fields that are used by the system to determine when the associated event occurred when applicable. Except for OSRs, each event is entered in the Subject Console.

      1. Consented: The consent signed date on the Subject Console > Consents page has been entered

      2. Screen Failed: The subject is not eligible on the Eligibility page

         1. If a Maximum Screen Failures value is entered in the Parameters tab, and milestones of Screen Failed and any other visit milestones have been selected from the Milestones tab, when a subject is marked as Not Eligible in the Subject Console any previously-added visit milestones already verified for this subject will be removed from Invoiceable Items (see below) and replaced with a Screen Failed milestone. If the Maximum Screen Failures value has been exceeded, the previously added visit milestones will be removed if the subject is marked as Not Eligible, therefore, no milestones will appear in Invoiceable Items for an ineligible subject. In either case, verification of the visit will be recorded.

         2. If a screen failure ratio is entered, after the initial screening failure number has been reached, the screen failure milestone will not be available in the invoiceable items until the ratio has been met.

      3. Enrolled: The On Study Date entered on the On Study page

      4. On Treatment: The On Treatment Date has been entered on the On Treatment page

      5. On Follow-Up: The On Follow-Up Date has been entered on the On Follow-Up page

      6. Off Study: The Off Study Date has been entered on the On Follow-Up page

      7. SAEs: The original SAE and any follow-ups of that original SAE only count as a single event

      8. OSRs: The original OSR (Outside Safety Report/external SAE) and any follow-ups of that original OSR count as separate events

   2. Treatment/Visits: as defined by the protocol calendar

      1. Cycle visit milestones can be specified in terms of All, Odd or Even cycles for open-ended study arms.

      2. If an open-ended milestone is specified, the first occurred visit of the relevant open-ended cycles (cycles beyond the no. of budgeted cycles) is listed as an invoiceable item. Even/odd cycles are determined based on the cumulative cycle no. for each arm.
         

5. Click the boxes in the Select? column for each visit you would like as a Milestone under the Protocol Events/Visits section, the Treatment section, and the Follow-Up section

   1. If there are multiple arms for the protocol, the Treatment Visit Dates under the Treatment section will be listed separately by arm
      

6. Click "Submit" once you have selected all applicable visits

7. All previously selected milestones will appear in the Financials Console Milestones tab

8. Enter the Negotiated Amount for subject statuses or events

9. If desired, use the Default Sponsor Requires Invoice column to indicate for which Milestone Event/Visits the sponsor requires to be invoiced (versus those that are paid automatically)

   1. This is a info-only field and does not drive any functionality.  It is optional to use this column.

   2. Your selection will show up in the Invoiceable Item tab once these Events/Visits are logged, but will still be editable.

10. Click "Submit" and then "Close"

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