Startup Financial Readiness Checklist

A hands-on checklist to make study startup financially launch-ready.

Set policies, scope, and evidence before activation

Most payment problems at study end are planted at startup. A clear, finance‑ready launch checklist prevents delays, disputes, and audit gaps by aligning policies, data, and evidence before the first subject is screened. Begin with principles and scope: define payment types (investigator grants, pass‑throughs, participant reimbursements, vendor services), their evidence requirements, and approval thresholds. Publish a unified policy that distinguishes reimbursements (repayment of documented out‑of‑pocket costs) from taxable compensation.

Ethics and regulatory guidance clarify acceptable practices for subject payments; see the FDA’s perspective at FDA subject payment guidance. Map your contract model to operational triggers and build change control in from day one. Each line item should trace to a verifiable event—activation, visits/procedures, milestone acceptances, or closeout tasks—and include rules for common modifiers (screen fails, early terminations).

Define accrual logic that mirrors cost behavior (unit‑of‑service vs. percent‑complete vs. straight‑line) and document assumptions so finance can forecast and reconcile confidently. Finally, assign RACI ownership for startup finance tasks across clinical operations, finance, vendor management, and site enablement.

Operationalize onboarding, evidence, FX/tax, and payment triggers

With policies set, operationalize a “no-surprises” launch. Start with master data: collect and validate site banking (IBAN/SWIFT or local equivalents), tax documentation (e.g., U.S. W‑9/W‑8BEN or local forms), legal names, and currency preferences before activation.

Reference IRS guidance for forms and status determination at IRS W‑9 and IRS W‑8BEN. For EU banking, reduce rejects by validating SEPA requirements and BIC/SWIFT; see the European Payments Council SEPA overview at EPC SEPA. Tie operational evidence to payment triggers. Configure your platform so site activation, first patient in, completed visits/procedures, and closeout tasks generate pre‑validated payable candidates linked to the governing contract term.

For participant reimbursements, make distinctions explicit in IRB/EC materials and SOPs—reimbursements (documented out‑of‑pocket costs) versus compensation/stipends (often taxable). Align with FDA guidance for research subject payments at FDA subject payment guidance. Apply three‑way matching—contract term, evidence, invoice line—and define exception playbooks with service‑level targets.

Governance, KPIs, and inspection readiness for launch and beyond

Inspection‑grade readiness comes from measurement and living evidence. Track activation-to-first-payment cycle time, first‑pass approval rate, exception aging (missing tax form, bank rejects, out‑of‑scope charge), and audit trail completeness. Review results weekly until steady state, then monthly.

Maintain an evidence binder for startup that links SOPs, rate cards, country packs, executed contracts/SOWs, configuration exports, and sample transaction trails. For cross‑border readiness, publish your FX policy (spot vs. averaged rate, booking window) and record rate source/timestamp per transaction. Keep stakeholders aligned. Provide transparent dashboards for sites and vendors showing pending documentation, hold reasons, and payment timelines.

Run launch retrospectives to capture lessons learned and update templates (e.g., consent language for reimbursements, banking form UX, country pack rules). With disciplined governance and automation, startup moves from email‑driven to event‑driven—accelerating activation, protecting compliance, and building site trust from day one.