Reading a Trial Budget
Part of Principal Investigator (PI) Training: The Business of Running a Site.
About 4 minutes. Free, in your language, no account needed.
Why this matters
E6(R3) says nothing about money. It does, in §2.2.2, require adequate staff, facilities and investigator time for the foreseen duration of the trial — and at almost every site those are bought with the budget.
An underfunded study is not a commercial problem that stays in the finance office. It becomes a compliance problem: the coordinator who is covering three trials, the monitoring visit nobody prepared for, the data entered late. Physicians who never look at the budget end up owning its consequences.
What a per-participant budget actually contains
Most commercial budgets are built per participant, with some fixed costs on top. Read yours in four parts.
Per-visit procedure costs. Line by line against the schedule of assessments. The failure is omission: an assessment in the protocol with no line in the budget is work you have agreed to do for free, and it is usually the expensive one.
Staff time. The coordinator hours per visit, and — this is the line sites most often leave at zero — your own time. Eligibility review, medical review, event assessment and data endorsement are the non-delegable duties from Module 1. If they are not costed, §2.2.2 is being satisfied out of goodwill.
Fixed and one-off costs. Start-up and ethics fees, archiving for the retention period, pharmacy set-up, equipment, staff training time, and close-out.
Pass-through and per-occurrence items. Screen failures, unscheduled visits, serious adverse event reporting, protocol amendments, re-consenting, monitoring visit support, audit or inspection support.
The five lines sites most often forget
Each of these is real work that happens at every trial and is missing from most first-draft budgets:
| Item | Why it bites |
|---|---|
| Screen failures | You do the work; some budgets pay only for randomized participants |
| Serious adverse event reporting | Hours of clinician and coordinator time, unpredictable timing |
| Amendments and re-consent | Every amendment is a re-read, a submission and possibly 40 conversations |
| Archiving | Runs for the whole retention period — years after the money stops |
| Inspection and audit support | Days of senior time, at no notice |
Payment terms, briefly
Three questions decide whether a nominally adequate budget is actually workable: when does money arrive (quarterly in arrears is common, and means you fund the first months yourself), what triggers payment (data entered, monitored, or query-resolved — the last can delay payment by months), and what happens if the study is terminated early (are start-up costs recovered).
Participant payments are a different question
Reimbursement for participant time, travel and inconvenience sits inside the budget but is governed separately: under §1.2.8 the IRB or IEC reviews both the amount and the method for coercion and undue influence. Treat it as an ethics item that happens to have a cost, not as a cost item. Module 11 develops this.
The one calculation worth doing
Before signing, work out the total cost of one participant through the whole study — including your own time at a realistic rate, screen failures at your real ratio, and a share of the fixed costs — and compare it to the per-participant payment.
If it does not cover, you have three honest options: negotiate, decline, or accept the shortfall deliberately with your institution's agreement because the study is worth doing for other reasons. All three are legitimate.
What is not legitimate is discovering the shortfall in month eight and absorbing it by cutting the time that §2.2.2 requires. That is how an underfunded trial becomes a non-compliant one.
Key takeaways
- E6(R3) sets no financial rules but §2.2.2 requires adequate staff, facilities and investigator time — which the budget has to buy.
- Read the budget in four parts and check every protocol assessment against a budget line.
- Cost your own non-delegable time; the commonest error is leaving it at zero.
- Price a whole participant before signing, and if it does not cover, negotiate, decline, or accept the gap deliberately — never by quietly cutting oversight.