Is this study budget worth it? A go/no-go check for small sites

A study budget arrives and the per-patient total looks reasonable. For a small site, this is the moment that decides whether the study pays for itself. Resolve the gaps you find before signing, and agree how amendments and added work will be paid.

A go/no-go check needs to answer one question honestly: can your site run this study well and at least cover its costs?

1. Price the visits against your real coordinator hours

Start with the schedule of assessments, not the total. For each visit, estimate the staff time it really takes, including preparation, data entry, queries and contact between visits, and compare it with what the budget pays.

Look closely at:

• Long or complex visits paid at the same rate as short ones.
• Screen failures, and whether and how many are paid.
• Unscheduled and early-termination visits.
• Work between visits: calls, eDiary and adverse event follow-up.

Use fully loaded costs: salaries plus overhead such as rent, software and administrative time. A shortfall on one visit may be offset elsewhere, but the study has to work at a realistic enrollment level, after start-up, training, regulatory work and close-out. A per-visit cost breakdown from your own data is also your strongest basis for a counter-offer.

2. Find the pass-through lines missing from the summary

Summary totals often leave out costs your site will pay anyway. For each item below, check whether it is included in the visit payments, a separately negotiated site fee, a sponsor-provided service, or a reimbursable third-party expense, and confirm any caps, documentation and prior-approval rules:

• IRB fees, including amendments and continuing review (if the sponsor doesn't pay the central IRB directly)
• Start-up, annual maintenance and close-out fees, including regulatory submissions, staff training, sponsor-system entry and any eSource or eREG costs
• Investigational product receipt, accountability, preparation, temperature-monitored storage, excursion handling and authorized return or destruction
• Lab kit storage, specimen processing and shipping, including dry ice and dangerous-goods requirements
• Imaging, ECGs or other procedures done by outside vendors
• Participant travel and parking reimbursement and participation payments: who funds and distributes them, and that amounts and schedule match IRB-approved materials
• Translation of patient-facing materials
• Extra monitoring visits, audits and re-consent time after amendments
• Recruitment and advertising costs, and pre-screening time
• Record storage and archiving after close-out, often for years as the regulations and contract require

Then check the payment terms, which can decide a small site's answer on their own: how often you're paid and how long invoices take, what triggers payment (visit completed, data entered or monitor-verified), any holdback until close-out, screen-failure caps, and whether your site can fund the work until payment arrives.

If an item isn't in the budget, assume your site pays for it unless the contract says otherwise. Ask for it to be added before you sign. Once the study is running, it is much harder to change.

3. Be clear about who bills what

Some procedures in a study are paid by the sponsor. Others may be routine care billed to the patient's insurance. Before you sign, make sure you know:

• Which items the sponsor pays for, and which, if any, are expected to be billed to insurance as routine care.
• Who is the billing provider of record for anything billed to insurance: your site, a practice you work with, or another provider.
• That nothing is billed twice. An item paid by the sponsor must never also be billed to the patient or the insurer.
• That the budget, the contract and the informed consent form all agree on what is free to the participant and what may go to insurance. Billing insurance for something the consent form calls free is a serious compliance problem.

Before any research-related insurance billing, have qualified billing staff complete a documented coverage analysis under the applicable payer rules, and reconcile it with the protocol, budget, contract and consent form. Routine care isn't automatically covered just because it happens during a trial; for Medicare, check whether the trial qualifies under Medicare's clinical trial policy. Many small sites keep it simple by having the sponsor pay for everything in the schedule of assessments. If your site works with a separate practice or hospital that bills for care, agree in writing who bills which items before the first patient is seen.

4. Check the coordinator model the sponsor expects

Budgets assume a staffing model, even when they don't say so. Ask yourself:

• Does the study expect a dedicated coordinator, or can it run with a coordinator shared across studies?
• Which tasks need licensed clinicians under your state's scope-of-practice rules, such as a licensed nurse for infusions, and which need protocol-specific training or certification?
• Will your PI and sub-investigators have time for the oversight the protocol requires?

If the realistic staffing model costs more than the budget allows, that is a "no", or a reason to renegotiate.

5. Make the decision on a single page

Before deciding, write a one-page summary for the people who will sign:

• Protocol snapshot and the patients it needs
• Competing studies at your site and in your area
• A realistic, aggregate enrollment estimate from your own records
• Staffing plan and coordinator hours
• Equipment and outside vendors needed
• Budget gaps found in steps 1 to 3, and what you asked for
• Main risks, including contract terms on indemnification, insurance, research-injury costs, termination payments and record retention (send legal terms to counsel)
• Your recommendation: go, go if specific changes are made, or no-go

6. How to decline cleanly

A short, professional decline protects your reputation and keeps the relationship open:

• Thank the team and say you've reviewed the protocol and budget carefully.
• Give a brief, honest reason, such as the budget not covering your costs for the visit schedule, or patient access not supporting the enrollment target.
• If a specific change would make it work, say so once.
• Say you'd welcome future studies in your therapeutic areas.

Declining well is better than accepting a study you then under-enroll. An honest decline keeps you in consideration for the next study.

Where Shortlisted™ fits

We don't set or negotiate your budgets; those decisions stay with your team. What we do is help study teams find your site earlier, so more of the protocols you review are worth this kind of check. Our Trial Radar watches for early signals that a study may need sites and checks each one against your site's real capabilities, and the fit checklist you approve keeps your coordinators focused on studies you can genuinely run. Shortlisted™ is paid only by sites, never by sponsors or CROs. There is no setup fee and no monthly retainer; a fixed fee becomes payable only when a qualified feasibility arrives, and it is never tied to enrollment, patient numbers or study budgets. We support your site's outreach; we don't refer patients or guarantee a place in any study. We can't promise that any study will select your site.

Want to see how your site looks to sponsors today? Start with a free Sponsor-Ready Audit.

The short version

Before you sign, price every visit against real staff time, find the pass-through lines the summary leaves out, settle who bills what, check the staffing the study assumes, and put the decision on one page. If the numbers don't work, decline clearly and keep the door open.

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