Every line a site or sponsor budget needs, from IRB fees to archiving, plus a working budget builder below. Enter your own figures, see the per-participant cost and copy the whole budget as CSV.
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| Line item | Basis | Qty | Unit | Total |
|---|---|---|---|---|
| IRB / ethics fees | One-time | 1 | $3,000 | $3,000 |
| Site initiation | One-time | 1 | $5,000 | $5,000 |
| Pharmacy / IP set-up | One-time | 1 | $2,500 | $2,500 |
| Screening visit | Per screened | 27 | $600 | $16,200 |
| Study visits | Per visit | 160 | $450 | $72,000 |
| Close-out and archiving | One-time | 1 | $2,000 | $2,000 |
| Direct costs | $100,700 | |||
| Institutional overhead (25%) | $25,175 | |||
| Total | $125,875 | |||
What you get on this page
Budget builder
Enter enrolment, visits and one-time costs. The builder adds screening for expected screen failures and applies overhead to direct costs. Nothing you type is stored or sent anywhere.
Estimated site budget
$125,875
$6,294 per enrolled participant, all-in
Defaults are placeholders that show the arithmetic, not benchmarks. Replace every figure with your own site quotes, fair-market-value rates and institutional overhead.
Budget structure
A sponsor's study budget and a site's budget look different, but they are built from the same parts. The sponsor budget adds central costs (CRO, central lab, data management, software, insurance, drug supply); the site budget covers what happens at the site. This template focuses on the site budget, because it is the one negotiated most often and the one where small omissions cost the most.
One-time costs incurred before the first participant: IRB or ethics review fees, contract and budget negotiation time, pharmacy set-up for investigational product, site initiation, staff training, and any equipment the protocol requires. Sites should invoice these whether or not the study enrols, and many sponsors pay them on contract signature or activation.
The core of the budget. Each visit on the schedule of assessments is costed from the procedures it contains (labs, ECGs, imaging, questionnaires) plus investigator and coordinator time. The per-participant cost is the sum of all visits a completing participant attends. Screening is usually costed separately because not everyone screened is enrolled.
Costs that happen only sometimes: screen failures, unscheduled visits, additional safety follow-up, SAE reporting, re-consent after an amendment, protocol amendment review fees, IRB continuing review, and participant travel or stipends. They are listed with a unit price and invoiced when they occur.
Close-out visit, query resolution after last participant, record archiving for the required retention period, and IRB closure. Most institutions then apply an overhead (indirect cost) percentage to direct costs; the rate is set by the institution and is often non-negotiable.
Per participant
$6,294
Participants
20
Total
$125,875
72% of direct costs
16%
12%
Line items
Use this as a checklist when drafting or reviewing a budget. Pricing basis shows how each item is typically charged.
| Line item | Category | Pricing basis | Often missed? |
|---|---|---|---|
| IRB / ethics initial review | Start-up | One-time, pass-through | |
| Contract and budget negotiation | Start-up | One-time | Yes |
| Pharmacy / IP set-up | Start-up | One-time | |
| Site initiation and training | Start-up | One-time | |
| Screening visit | Per participant | Per screened participant | |
| Treatment and follow-up visits | Per participant | Per completed visit | |
| Investigator and coordinator time | Per participant | Built into each visit | Yes |
| Questionnaires and ePRO training | Per participant | Built into visits | Yes |
| Screen failures | Invoiceable | Per screen failure, often capped | Yes |
| Unscheduled visits | Invoiceable | Per occurrence | |
| SAE reporting and follow-up | Invoiceable | Per SAE | Yes |
| Protocol amendment and re-consent | Invoiceable | Per amendment / per participant | Yes |
| IRB continuing review | Invoiceable | Annual | |
| Participant travel and stipends | Invoiceable | Per visit, pass-through | |
| Monitoring visit support | Invoiceable | Per visit | Yes |
| Close-out and archiving | Close-out | One-time | Yes |
| Institutional overhead | Overhead | Percentage of direct costs |
Start from the schedule
Every row of the schedule of assessments is a procedure and every column is a visit, so the same grid tells you what each visit costs. Build the study schedule first, then cost it. In Capture the blank eCRF PDF includes a visit-by-form matrix generated from the approved study, which doubles as a checklist when you cost each visit.
| Assessment | Scr | D1 | W2 | W4 | W8 | W12 | FU |
|---|---|---|---|---|---|---|---|
| Physical exam | |||||||
| Safety labs | |||||||
| ECG | |||||||
| Questionnaires | |||||||
| IP dispensing |
The software line
Software is usually a sponsor-side cost, and for small studies it can be surprisingly large once set-up fees, per-site charges and change orders are added. Capture has no set-up fee and no per-site fee: you build and test the full study free, and pay only when it goes live with real participants.
Pre-launch readiness
1 site activated
1 form not yet approved
Upload a protocol and let the AI Study Generator draft the visits and forms you will cost.
Negotiation
Most budget disputes come from items nobody priced, not from arguments about rates. These are the patterns that come up again and again.
A visit is not just its procedures. Scheduling, reminders, source documentation, eCRF entry, query resolution and monitoring visits all take coordinator hours. Estimate them per visit and include them explicitly.
If the expected screen-failure rate is high, screening is a large share of site effort. Agree a price per screen failure, and whether it is capped, before the first participant is screened.
Every amendment means IRB review, retraining and often re-consent. Include a per-amendment fee and a per-participant re-consent fee. For the software side, see protocol amendments without change orders.
Queries continue after the last visit, and records must be archived for years. Budget both, and agree what share of payments is held back until close-out.
Before you sign
Each column of the schedule of assessments has a price that covers procedures and staff time.
Screen failures, unscheduled visits, SAEs, amendments, re-consent.
Check which lines the institutional rate applies to, and whether pass-through costs are excluded.
Start-up payment timing, visit payment frequency and any holdback until close-out.
Rates consistent with fair market value for the region, documented.
For multi-year or multi-country studies, agree currency and any annual adjustment.
Start-up costs, per-participant visit costs, invoiceable conditional costs (such as screen failures, unscheduled visits and SAEs), close-out costs and institutional overhead.
Cost each visit on the schedule of assessments from its procedures plus investigator and coordinator time, then add up the visits a completing participant attends.
Usually as a per-screen-failure fee, sometimes capped at a number or a ratio of enrolled participants. The budget builder above adds screening costs for your expected screen-failure rate.
An indirect cost percentage that institutions apply to direct study costs to cover facilities and administration. The rate is set by the institution.
No. The defaults only show how the calculation works. Replace every figure with your own quotes and rates.
It depends on the vendor and study size. Capture has no set-up or per-site fee, and you can build and test the study free before paying. See the EDC cost calculator for typical ranges.
Use "Copy budget as CSV" in the builder and paste it into Excel or Google Sheets.
Keep exploring
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Build and test your whole study free. Pay only when you go live.