4. Subject Visit Tracking

Navigating to the Subject Visit

1. Begin on Home Page > Subjects menu > CRA Console

2. Select a protocol by entering the protocol number in the Select Protocol field

3. In Accrual Details box, click on Epic MRN hyperlink for the patient whose visit is being updated

4. Click the Calendar Vertical tab

5. Click on the Study Visit (ex: C1D1) in the Calendar Horizontal tab

Entering Visit Information

If the patient visit occurred as planned:

1. In "Visit Details" box, complete the following Required fields: Confirm correct visit date, Visit Status is marked as "Occurred"

2. Click "Submit and Close"
   
   

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If the patient visit does NOT occur as planned:

1. In "Visit Details" box, complete the following Required Fields:

   1. Date the visit took place (change it to the correct date if it’s not on the 'Planned Date')

   2. Visit Status

      1. "Occurred" (if "Planned Date" is not the same as actual occurred date)

      2. "Missed" (if whole visit was missed)  

      3. “N/A” (if the visit is not applicable for that subject) Once the visit is Marked “N/A”, click “Submit & Close”

2. In the Procedures box, complete the following Required Fields

   1. Procedure Date (only if the procedure has taken place on a different date than the visit date) You do not need to enter a date if the procedure is on the same date as the visit date.

   2. Procedure Missed (only use if the procedure should have taken place but it didn’t)

   3. N/A (only use if the procedure is not needed at this visit)

3. If a procedure is labeled with a TBD footnote:

   1. The procedure is billable to the Sponsor unless it is performed as the subject's standard treatment. Billing staff are instructed to bill the procedure to the study if this is not marked SOC.

   2. This procedure must be marked SOC (standard of care) whenever applicable.  

   3. This is the only time a coordinator should check or uncheck the SOC checkbox next to a procedure.
      

   4. Once you check the SOC box, you will get a pop-up box asking the reason for the change.  Enter the reason and your full name, in case the Financial Coordinator has questions.
      

4. Enter Comments as appropriate

   1. Comments added in the Clinical Comments field will populate on the Subject Calendar with a (C) next to the visit.
      
      

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5. Once the data collection for the visit is complete, enter the Data Collection Complete Date

6. Click "Submit" and "Close"
   
   

7. If the patient visit is NOT scheduled to occur as planned

   1. In "Visit Details" box, complete the following Required Fields:

      1. Update "Visit Date" with new/corrected Planned Visit Date

      2. New planned date may require a calendar reset. This will change future planned visit dates based on the new date manually entered for the current visit.
         
         

         1. Just below the visit status, click the drop down for "reset calendar" and there will be 3 potential options to select: all visits, current cycle, or current segment.

         2. Example: Visit 1 is for surgery and the visit gets pushed back 10 days due to a transportation issue with the patient. Visit 2, per the protocol, has to occur 20 days post surgery with a window of +/-3 days. In this example you would click the drop down to reset the calendar and select current segment when logging Visit 1 so Visit 2 will populate with the correct date.

         3. If all visits need to be moved as a result of a shift like above select all visits in the drop down. If the visit 1 was in a set of cycled visits (ex: C1D1, C1D15, C1D22, etc) select current cycle in the drop down option for resetting the calendar.

         4. In the calendar reset dropdown there may only be one option available, "all visits". If that is the case, select that and click submit at the bottom to save your work.

   2. In the Procedures box, complete the following Required Fields:

      1.  

      2. Procedure Missed (if applicable)

      3. Procedure Missed Count (if applicable)

   3. Enter Comments as appropriate

   4. Once the data collection for the visit is complete, enter the Data Collection Complete Date

   5. Click "Submit and Close"

8. If the patient visit is N/A

   1. In "Visit Details" box, complete the following Required Fields:

      1. Update "Visit Status" to N/A

   2. In the Procedures box, check the "N/A" box for any/all procedures at this visit

   3. Enter comments in the auto-generated pop-up window

   4. Click "Submit and Close"

   5. These N/A visits will not show up in the last visit column of the CRA console. Only occurred visits will

9. If a visit was marked as N/A, but the patient ended up coming in:

   1. Select the visit from the subject calendar

   2. In the bottom right, click the "Delete" button

   3. In this context, the Delete button acts as a reset, it deletes the information entered within that visit - it does not delete the visit from the calendar completely

*Institutional required fields marked in red, bold font 

Open-Ended Treatment Visits

• If the protocol states that a segment's cycles are open-ended, those 'extra' visits won't populate on the subject's calendar until there are less than 4 'Planned' visits showing on the calendar.

• OnCore automatically adds a new set of cycles and visits to the subject’s calendar (in essence, OnCore tacks on a new open-ended segment). The new cycles and visits immediately follow the last cycle of the current segment.

Logging Additional Visits

• 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:

• 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 void