5. Subject Accrual, Calendars and Visits

Subject Accrual Information:

Subject accrual information can be viewed from the PC console. To view a protocol's subject accrual information:

• From the Home Page > Protocols menu > PC Console
  • You will automatically be brought to the Main Tab 
• Type the protocol number into the Select Protocol field. The drop down will automatically fill as you type - select the correct protocol when it appears.
• Select "Accrual" from the left vertical tab. Note: OnCore defines subjects as accrued to a study one they have an "On Study" date listed.
  • The "Current Subject Totals" at the top of the page will list the number of subjects currently at each study status
  • The "Cumulative Subject Totals", lists the number of subjects to have achieved each status at some point in the life of the protocol, regardless of the subject's current status.
  • The "Accrual Details" table lists all subjects accrued to the protocol and their corresponding key information

Subject Calendars and Visits:

• From Protocols menu > PC Console > Accrual:
  • Select a patient's Epic MRN hyperlink. This will take you to that subject's Subject Console
  • Select "Calendar" from the left vertical tab
    
• A protocol calendar defines a schedule of visits (when a subject is to be seen) and what treatment will be done during each visit. Similar to the billing Grid, procedures will be listed on the left side of the calendar and time points (or Milestones) will be listed at the top of the calendar.
  • Planned Date
    • A calculated date from OnCore based on the patient status dates. Patient status dates drive which areas of the calendar that can be updated by the study team. This may be different than the Visit date.
  • Visit Status
    • Status of that particular visit. The different visit statuses are "Planned", "Occurred", "Missed", or "N/A".
  • Visit Date
    • Date that the visit took place

• • Selecting the time point or Milestone  hyperlink will direct you to the Subject Visit Update page which provides details on what occurred on a visit-by-visit basis
    • Visit details, such as visit date and visit status will be listed at the top of the Subject visit Update page
    • Procedures set to occur at that visit based on either the protocol or the finalized budget are listed in the Procedures table
      • If the Procedure Date box is left blank, OnCore assumes that the procedure occurred on the Visit Date. If a certain procedure occurred on a different date than the Visit Date, the date that it occurred will be entered in the Procedure Date corresponding to the Procedure. This is done by the research coordinator logging visits for the subject.
    • Additional Procedures:
      • The Additional Procedure button only becomes available after you click "submit". Avoid clicking "submit and close" because that will take you out of the visit. 
      • On the Subject Visit Update page, any procedures listed with a hyperlink have been added in addition to the schedule of events for that particular visit. OnCore calls these Additional Procedures. 
      • Clicking on the additional procedure hyperlink will display the study team's reason for adding the procedure to that visit.

Optional Calendar Segments

OnCore calendars can be built in a variety of ways in to fulfill protocol requirements. With the upgrade to OnCore v15 came the ability to assign Optional Calendar Segments. Optional calendar Segments can be used if a portion of the calendar is not required for all subjects. Optional Treatment Segments can be used for the following subject status triggers:

• Consent Signed
• On Study
• Off Treatment
• Off Study

If a calendar segment is built using the Optional Calendar Segment, this segment will not automatically populate on the subject calendar. Instead, when a subject reaches a status that uses Optional Calendar Segments, you will receive a message like this:

To add the Optional Calendar Segment to your subject's calendar, select "Manage Optional Segments" in the calendar tab:

A window will appear providing segments that can be included in the subject's calendar:

Additional Visits for CRAs:

• Subjects Menu > Subject Console > Additional Visits tab
• Click "New" to display a Subject Visit Update page where visit details can be entered. 

• After a Visit Date is entered and the "Submit" button is clicked, an Additional Procedures button appears at the bottom of the page. 
• Select the additional visit procedures from the pop-up box then click "Submit"

• If you do not receive an additional pop-up box then make sure your pop-up blocker is disabled in the upper right hand corner of your screen. 
• When selecting an additional procedure DO NOT select from Charge Master or Free-text procedure. ALWAYS select from "Protocol Procedures". See below:

• If you do not receive an additional pop-up box then make sure your pop-up blocker is disabled in the upper right hand corner of your screen. 
• When selecting an additional procedure DO NOT select from Charge Master or Free-text procedure. ALWAYS select from "Protocol Procedures". See below:

• The additional procedure "reason for adding" will need to be filled in

• Additional visits do not appear on the subject calendar. Additional visits cannot be deleted once placed on an invoice, even if that invoice has been voided.