Clinical Research Patient Scheduling Software

Patient Scheduling in a Clinical Research Practice

A protocol sets the visit plan before the first person enrolls. There is a screening visit, a first dose or baseline visit, treatment visits and follow-up visits, each with a target day and a window around it. Patient scheduling for a research site turns that plan into a calendar for each person, counted from their own start date. Staff book inside the window and see a warning when a date falls outside it, since an out-of-window visit is a protocol deviation. Each visit type holds the time, the staff and the space it needs. Some need fasting labs early in the day. Some hold an infusion chair for most of a day. When a person also has a normal visit on the same day, the schedule shows both, so routine trial care and unrelated care stay on separate lines or claims. Reminders go out before every study visit.

Why Is Patient Scheduling Different in Clinical Research?

A study visit is not booked when it suits the patient. It is booked when the protocol says, within a window that may be narrow. Miss the window and the visit becomes a deviation the site has to report to the sponsor. Booking from a blank calendar invites those misses, so each person's study calendar has to be built from the protocol and their start date.

Study visits also need more than a provider. A treatment visit may need a coordinator, a nurse, a chair, timed lab draws and a slot to process samples. Many sites run trials inside a busy practice, so those resources are shared with normal patients. The schedule has to hold them for study visits without blocking the rest of the clinic.

Then there is the billing side of the calendar. A person may see their regular doctor in the morning and come back for a study visit in the afternoon. For Medicare, trial and non-trial services go on separate lines. For Medicare Advantage members, an institutional provider must split them onto separate claims. Patient scheduling sets this up by keeping study visits and normal visits apart on the same day.

What Clinical Research Patient Scheduling Software Handles

Trial and non-trial services on the same day

Medicare asks providers to put clinical trial and non-trial services on separate lines when both are on one claim. Booking study and normal visits as separate visit types keeps them apart from the start. (CMS Medicare Claims Processing Manual, Chapter 32, Sections 69.5 and 69.9 (billing trial and non-trial services; managed care enrollees))

Advantage members seen for both on one day

For Medicare Advantage members, institutional providers must not bill outpatient trial services and unrelated services on the same claim. Trial services bill to Original Medicare, and the unrelated care bills to the plan. (CMS Medicare Claims Processing Manual, Chapter 32, Sections 69.5 and 69.9 (billing trial and non-trial services; managed care enrollees))

Unscheduled visits for complications

Medicare covers care to diagnose and treat complications from taking part in a trial. An unscheduled visit is booked as its own type, and staff decide how it bills once the reason is known. (CMS National Coverage Determination 310.1: Routine Costs in Clinical Trials)

Visits only for study data

Services done only to collect study data, and not used to manage the person's care, are not covered by Medicare. A visit made up of only these services is booked as sponsor-paid. (CMS National Coverage Determination 310.1: Routine Costs in Clinical Trials)

Stipends that build visit by visit

FDA guidance says payment to participants should build as the study goes on, not wait until the end. Completed visits are marked on the schedule, so the coordinator knows which visits earned a payment. (FDA Guidance: Payment and Reimbursement to Research Subjects)

How Does Clinical Research Patient Scheduling Software Work?

1. 1. Build visit types from the protocol

   Each protocol visit gets a visit type with its target day, window, length and resources. Screening, baseline, treatment and follow-up visits are booked from these types.

2. 2. Set each person's calendar

   When a person starts the study, their visit dates are worked out from their start date. Staff see the full set of target dates and windows at once.

3. 3. Book inside the window

   Staff book each visit inside its window and get a warning if a date falls outside. Each visit stays tied to the review done in study financial clearance.

4. 4. Send reminders

   Reminders go out by text or email before each study visit through patient engagement for trial participants. Notes such as fasting or bringing a diary can be added.

5. 5. Mark the visit done

   When a visit is complete, staff mark it done on the schedule. The services move on to study charge assembly, and the coordinator can see the visit count for stipends.

Clinical Research Patient Scheduling Software vs. Generic Software

Who Uses It in a Clinical Research Practice

• Research coordinator: A calendar for each person built from the protocol, with windows shown and no counting by hand.
• Front desk: A clear view of which of today's visits are study visits and which are normal care.
• Clinic manager: Shared chairs, rooms and staff booked without study visits crowding out the rest of the clinic.