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- If the patient visit occurred as planned:
- In "Visit Details" box, complete the following Required fields: Confirm correct visit date, Visit Status is marked as "Occurred"
- Once the data collection for the visit is complete, enter the Data Collection Complete Date
- Click "Submit and Close"
- If the patient visit does NOT occur as planned:
- In "Visit Details" box, complete the following Required Fields:
- Correct "Visit Date"
- Visit Status
- "Missed" (If whole visit was missed)
- "Occurred" (if "Planned Date" is not the same as actual occurred date)
- In the Procedures box, complete the following Required Fields
- Procedure Date
- Procedure Missed (if applicable)
- Procedure Missed Count (if applicable)
- If a procedure is labeled with a TBD footnote:
- The procedure is billable to the Sponsor unless it is performed as the subject's standard treatment.
- This procedure must be marked SOC (standard of care) whenever applicable.
- This is the only time a coordinator should check or uncheck the SOC checkbox next to a procedure.
- 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.
- Enter Comments as appropriate
- Comments added in the Clinical Comments field will populate on the Subject Calendar with a (C) next to the visit.
- Comments added in the Clinical Comments field will populate on the Subject Calendar with a (C) next to the visit.
- Once the data collection for the visit is complete, enter the Data Collection Complete Date
- Click "Submit" and "Close"
- In "Visit Details" box, complete the following Required Fields:
- If the patient visit is NOT scheduled to occur as planned
- In "Visit Details" box, complete the following Required Fields:
- Update "Visit Date" with new/corrected Planned Visit Date
- 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.
- 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.
- 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.
- 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.
- 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.
- In the Procedures box, complete the following Required Fields:
- Procedure Date
- Procedure Missed (if applicable)
- Procedure Missed Count (if applicable)
- Enter Comments as appropriate
- Once the data collection for the visit is complete, enter the Data Collection Complete Date
- Click "Submit and Close"
- In "Visit Details" box, complete the following Required Fields:
- If the patient visit is N/A
- In "Visit Details" box, complete the following Required Fields:
- Update "Visit Status" to N/A
- In the Procedures box, check the "N/A" box for any/all procedures at this visit
- Enter comments in the auto-generated pop-up window
- Click "Submit and Close"
- These N/A visits will not show up in the last visit column of the CRA console. Only occurred visits will
- In "Visit Details" box, complete the following Required Fields:
- If a visit was marked as N/A, but the patient ended up coming in:
- Select the visit from the subject calendar
- In the bottom right, click the "Delete" button
- 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
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