Site payments by visits

The fee schedule, accruals for completed and verified visits, statements confirmed by the site, the payment, the holdback and the act.

Site payments in YouEDC Trials pay each site for the work its contract names: the visits of its patients, the procedures done in them (an ECG, a biopsy), screen failures and one-off items. The fees come from the study's fee schedule, the facts come from YouEDC Capture by themselves, and a visit becomes payable only when its data meet the payment condition: complete, verified by the monitor, approved by the data manager. The project administrator makes a statement for a month, the sponsor approves it, the site confirms it and the payment is recorded. The tab Site payments of the study's YouEDC Trials section opens it; the Portal Owner switches the function on (“Site payments by visits” in Functions and limits).

Who sees what

• The project administrator keeps the fee schedule and the budget, adds items and advances, makes and submits statements, issues the approved ones and records the payment.
• The sponsor (a viewer member of the study) sees the amounts by site and the statements sent to them, and approves a statement or returns it with a reason. In a study without a viewer member another project administrator approves. Whoever submitted a statement never approves it.
• The investigator sees only their own sites: the visits and what they earned, the statements issued to the site; they confirm a statement and may give the site's invoice number.
• Monitors and data managers see which visits wait for SDV or approval and what holds them, without any amount: payment must not steer the review of the data.

Patients are named by their study codes only, in the statements and the act as well. The arm of a patient never decides a fee: forms for the unblinded team are not looked at.

The fee schedule

The schedule is kept in versions. A saved version never changes; a new one applies to visits from its date, and what was earned before keeps its fee. Each version names the protocol version or amendment it follows; the version is shown on the dashboard, the statement and the act. A version holds:

• the fee of each visit of the schedule, a fee for any unscheduled visit that has none of its own, and the fee of a screen failure. An empty fee means not paid; a 0 for a visit means it is not paid even when the “any unscheduled visit” fee applies (an adverse event log, for example);
• a site's own fee, filled only where its contract differs from the study's;
• procedures: a fee tied to a form (paid when the form is complete in the visit, an ECG form for example) or to a yes/no field (paid when it is “yes”, a biopsy done), in chosen visits or in any;
• VAT: 0, 10 or 20% or “not subject to VAT” with a note for the act, and a site's own rate (a state hospital is often not subject to VAT);
• the holdback (0–50%), the screen failure cap and the advance share, explained below.

The study has one currency: it cannot change once a statement exists. Every version, fee, site rate and procedure goes to the audit trail with the reason given.

When a visit becomes payable

A visit is payable on the day it meets the condition of the version in force on the visit's day:

• Complete: every form of the visit is complete. Fast, but the site is paid for data nobody checked yet.
• Complete and SDV-verified (recommended): complete and every form the study's SDV plan requires is verified by the monitor. With partial SDV, forms outside the sample need only be complete. This follows the risk-based monitoring of ICH E6(R3): the sponsor pays for data it has checked to the extent it decided to check them.
• Complete, verified and approved by the data manager: available when the study uses the data manager's approval (YouEDC Capture, data review settings).

The tick and no query is open on its forms adds to any condition: the visit waits until its queries are closed. On the page Visits and accruals each visit shows what it waits for; each line of a statement shows which condition it met and on what day. A procedure is paid on the same condition, checked on its own form.

A screen failure (a patient who left the study without being randomised, in a randomised study) is paid on the day the status was set. With a cap “one paid per N randomised patients of the site”, the screen failures over the cap are shown as over the cap and are not billed; they become payable as the site randomises more patients.

The dashboard and the budget

The budget of a site is its planned patients (the site's enrolment target, unless entered on the fee schedule page) times the fees of the scheduled visits, plus the planned screen failures and other planned amounts (start-up, close-out, archiving). The dashboard shows, for each site and in total: the budget, what is earned but not billed, billed (net of the statements past the draft), paid, the holdback kept, the advance still to recoup, what remains and the share used. The chart shows what was earned month by month, added up, against the budget spread evenly over the enrolment period. All the amounts are net of VAT.

A statement from draft to payment

1. Draft: the project administrator chooses the site and the month (or the dates). The statement takes every payable visit, procedure and item of the site up to the end of the period that is not billed yet, earlier ones too. A draft can be checked, recounted and thrown away; a site has one draft at a time.
2. Submitted: the content is frozen and its SHA-256 recorded.
3. Approved by the sponsor, or returned with a reason: the statement goes back to draft, the reason is shown on the draft and stays in the audit trail.
4. Issued to the site: the statement gets its number (site–sequence, like 01-3).
5. Confirmed by the site: the investigator agrees and may give the site's invoice number.
6. Paid: the administrator records the date and the payment order.

A visit is billed once: a key that is in a statement never goes into another. Every step, with who did it and when, goes to the audit trail.

Holdback, VAT and advances

The lines of a statement are net. The holdback is a share of the net of the visits and procedures (never of items) kept until the site's close-out; then “Pay out” adds it as an item to the site's next statement. An advance paid to the site ahead is recorded as an item of its own kind and is recouped from the site's next statements at the version's share of each statement's net after holdback (100% by default) until it is all recouped; a recoup is a negative line. VAT is counted on the net after the holdback and the recoup, by the rate of the version or the site's own; the statement shows net, holdback, VAT and to pay.

Corrections

When a billed visit loses its condition on evidence (a form reopened, its data changed after the day it was billed for, the data manager’s approval withdrawn), nothing changes by itself: the dashboard and the next draft warn about it. A wider SDV sample later (a site’s risk raised in the monitoring plan) does not take back a visit earned under the plan in force then. The administrator adds a correction to a draft with the reason: a negative line of the same amount. When the visit meets the condition again, the next statement bills it again.

Excel, the act and SHA-256

Each statement downloads as an Excel file and as a PDF act for the accounting department: the study, the protocol version, the site and its principal investigator, the period, who prepared, approved, issued and confirmed it, the lines with the condition met, net, holdback, VAT and to pay, the signature lines of both parties and the SHA-256 of the content, which shows the act matches the statement in the portal. “The act” opens it as a page before printing. Each download is in the audit trail.