Guide, published
Getting paid for every procedure: reconciling a clinical trial agreement fee schedule
An editorial reconciliation workflow for completed activity, contractual triggers, invoices and remittances, without assuming every procedure is payable.
In this guide
The agreement determines what is earned
A clinical trial agreement connects operational obligations with payment conditions. The executed agreement, budget and amendments determine which activity is payable, the amount, the trigger and any invoice requirements. A completed procedure can be clinically necessary without being separately invoiceable. Finance should not infer entitlement from a procedure name or a worksheet total. Begin with the signed documents and identify the current applicable fee schedule.
An original University of Rochester CTA template illustrates how an agreement can tie reimbursement to an attached budget and contain specific invoice provisions. It is a contractual example revised in 2014, not legislation or a current universal standard. Do not copy its payment periods into another study. Use your actual agreement and obtain clarification from the sponsor when its milestone conditions are unclear.
Map procedures to milestones before the visit
Build a review table with study, site, milestone label, negotiated amount, earning trigger and payment method. The source procedure name and sponsor budget label may differ. A visit fee may include several assessments, while an additional procedure may require prior approval. Record these distinctions before they become a pile of completed work awaiting interpretation. Keep the agreed mapping available to coordinator and finance staff.
Kyros Trials supports study/site milestone fees and entered or verified triggers. Choose the trigger that reflects the agreement, not the one that produces the earliest item. If the contract requires review completion, source entry alone may not release the fee. Review sample work through the trigger with the coordinator and finance team. Software configuration helps apply the rule but does not interpret ambiguous contract language on the site’s behalf.
Separate completed, earned, invoiced and paid
These states are not interchangeable. Completed describes work performed. Earned describes conditions met under the agreement. Invoiced describes a request linked to eligible items. Paid describes the recorded payment status, which still needs reconciliation with the sponsor remittance. Keep a trail between those states so staff can explain why a procedure has not yet become an invoice line or why an invoice remains outstanding.
Illustrative example: a $650 visit fee and a $120 additional procedure both meet their verified triggers. Eligible items total $770. Selecting them into a sample invoice creates a linked request for $770; it does not prove sponsor acceptance or receipt of money. These amounts are hypothetical, not Kyros Trials customer results or recommended fees. Check prior automatic payments and contract inclusions before requesting the same amount again.
Review unbilled work without double counting
Group eligible items by study and participant code, then compare them with the fee schedule and completed-work evidence. Investigate items missing a trigger, items with an unexpected amount and items already linked to an invoice. A broad accrued total can include work that is not currently invoiceable. Make the definition explicit so a finance report does not present every completed activity as cash due.
In Kyros Trials, eligible unbilled work retains its relationship to the underlying record and invoice linkage. The fee schedule, source status and selected items should agree before invoice creation. An item paid through another sponsor process may need reconciliation rather than a duplicate request. Record the reason for a variance and its responsible reviewer. The editorial sequence is agreement, activity, trigger, invoice or automatic payment, remittance and unresolved difference; it is not an FDA-mandated billing process.
Prepare the invoice with data minimization
A sponsor invoice should identify the sponsor, study, site, eligible lines and amounts clearly enough for finance review. Use coded participant references rather than names where appropriate, but do not assume a code is automatically de-identified. Service dates, notes and free-text descriptions can contain sensitive information. Review the printable document before sharing it and follow the agreement’s disclosure and transfer requirements.
Do not include clinical values merely to prove a procedure occurred unless the authorized process requires them. Finance can often work from a coded item and milestone context, but the site must determine the appropriate disclosure. The public sponsor-invoicing page does not promise PHI-free output. Treat data minimization as a review step, not a marketing guarantee or a reason to bypass a sponsor’s secure submission process.
Corrections and final reconciliation need history
If an invoice is wrong, preserve the original and document the correction rather than overwriting it. Kyros Trials uses a reason-required void workflow that returns linked items to Unbilled for a corrected invoice. Authorized staff review the reason and resulting item state. Marking an invoice sent is a status action, not proof of automatic delivery; marking paid is not bank reconciliation.
Use the site budget calculator for planning costs, not for proving earned revenue. At study close, reconcile expected work, earned items, invoices, payments, adjustments and unresolved variances under the agreement. Holdbacks, deadline rules and final payments are contract-specific. Keep a named owner and supporting records for each open question. This guide helps organize reconciliation; it does not promise that every procedure will be paid or create contractual entitlement.
A practical reconciliation meeting
Bring the active executed budget, a coded completed-work list, eligible unbilled items, invoice detail and available remittance records to the same review. Assign one person to explain the source event and another to explain the agreement condition. Check whether an invoiceable milestone includes multiple procedures and whether an extra item requires approval. Keep questions in a variance list with an owner rather than changing the amount merely to match a desired total.
Select one sample item and trace it from completion to the earning trigger, invoice linkage and payment record. If the sponsor paid automatically, confirm whether a separate invoice is appropriate. If the amount differs, retain the contractual explanation and adjustment history. This meeting is an editorial review method, not a mandated accounting standard or a promise that reconciliation recovers money. Its usefulness depends on accurate source evidence, the executed agreement and staff follow-through.