Clinical Trial BudgetCalc — Private Prototype

Guided study intake

Start with a fictional scenario. Every assumption is editable. Screening volume and enrolled subjects are intentionally separate.

Study name

Cases requiring chart reviewExpected enrollmentsScreening weeksInvestigators

Enter expected enrollments only if you have a defensible estimate; 0 means not yet estimated, not that no one will enroll.

Why these questions matter

Chart reviews drive prescreening workload even if a case never enrolls. Enrollment forecasts drive consent and procedure support. Screening weeks determine average capacity required; peak coverage may be higher.

Protocol workload estimator

Specify effort per activity. These are demonstration values, not institutional standards.

Chart review hours per caseCases requiring outreach (%)Outreach hours per contacted caseOther enrollment hours per subjectDay-of-surgery hours per coordinatorCoordinators per surgery

Prescreening hours—

Enrollment + surgery hours—

Total modeled hours—

Show rationale and formulas

Staffing & capacity

Calculate required FTE independently of how many coordinators are currently available.

Paid hours / week per FTEProductive capacity (%)Available coordinator FTEPeak simultaneous staff required

Average FTE needed—

Minimum whole-person headcount*—

FTE gap—

*The headcount is the greater of workload-based whole-person staffing and your entered simultaneous coverage requirement. It is not a validated shift schedule.

Why this result?

Surgical coverage must also be checked against actual procedure dates, overlapping cases, shift duration, and which activities can be performed concurrently. Two coordinators × 9.25 hours = 18.5 labor-hours, not necessarily 9.25 hours of simultaneous coverage.

Preliminary budget estimator

Illustrative labor-based estimate only. This is not a complete sponsor budget.

Fully loaded cost per labor hour ($)Proposed sponsor billing rate ($/hour)Overhead on eligible direct costs (%)Additional direct costs ($)

Modeled labor cost—

Illustrative sponsor request—

Difference*—

Calculation and interpretation

*The difference is not profit: it excludes unmodeled costs and any billing restrictions. Confirm overhead eligibility, rate policies, and whether fixed staffing support duplicates per-activity charges before proposing a sponsor budget.

Learning library

Build judgment, not just totals. Expand each concept to understand how it changes a budget.

Screened versus enrolled subjects

Every chart review creates workload. Only enrolled subjects trigger consent, study-specific treatment, and visit activities. Never use the screened count as enrolled count without an explicit assumption.

FTE versus headcount

FTE measures total labor capacity; headcount counts people. Coverage constraints can require more people than average workload alone suggests.

Productivity factor

Paid hours are not always available for protocol-specific activities. Apply a factor for competing commitments only when those hours have not already been removed from the workload definition.

Milestone versus per-subject payments

Fixed or quarterly milestones can fund predictable staffing capacity. Per-subject payments scale with enrollment. A hybrid can cover both, but the same labor must not be charged twice.

Cost versus sponsor price

Fully loaded internal cost and proposed sponsor billing rate serve different purposes. Separate institutional cost recovery, overhead, pass-through charges, and negotiation assumptions.