Site finance

Invoiceables: what research sites forget to bill

By TrialNotice · Updated
Hand writing notes on a printed budget sheet next to a calculator, navy binder, and coffee mug
Short answerInvoiceables are billable items outside per patient visit payments, such as startup fees, pharmacy setup and maintenance, amendment processing, monitor changes, storage, and closeout. SCRS calls many of them hidden costs that are not accounted for in study budgets. Published academic fee schedules show real amounts, such as up to $1,618 per pharmacy amendment at Johns Hopkins.

What counts as an invoiceable?

Costs that may or may not occur during a study, or that occur once, billed separately from per visit payments. SCRS describes many as hidden costs generally not accounted for in budgeting, and its guide groups them by protocol startup, events during the study, and closeout (SCRS). SCRS does not guarantee sponsors will accept every item, but considers them realistic and reasonable (SCRS).

What do institutions actually charge?

Published fee schedules from academic centers show real amounts. Community sites set their own rates, but these are useful anchors.

ItemPublished example
Administrative startupAbout 250 hours of combined personnel time for startup activities (Johns Hopkins); $6,500 in one template (St. Luke's)
Clinical research finance startupUp to $5,980, about 40 hours of budget and contract work (Johns Hopkins)
Regulatory startupUp to $2,948 (Johns Hopkins)
Pharmacy amendment managementUp to $1,618 per amendment (Johns Hopkins)
Protocol amendment$500 with consent changes, $250 without (LSU Health)
Budget or contract amendment$450 (LSU Health)
Monitor or CRA change$500 per change (LSU Health; St. Luke's)
Monthly drug storageUp to $170 per month (Johns Hopkins)
Monitoring visitUp to $160 per on site visit (Johns Hopkins)
Document storage or archiving$750 to $1,000 (LSU Health; St. Luke's)
Closeout$1,500 (St. Luke's)

Which items do sites forget most?

  1. Amendment processing, especially pharmacy and consent updates.
  2. Monitor changes, which mean retraining a new CRA on the site.
  3. Extra or unscheduled visits.
  4. Record storage for the full retention period.
  5. Prescreening and screen failure work beyond the cap.
  6. Training time, where the contract allows it.

How do you capture them?

  • Put a full invoiceables list in every budget negotiation. See the budget negotiation checklist.
  • Log each event the day it happens, then invoice on a fixed schedule.
  • Use SCRS's free Site Invoiceables Guide as a reference (SCRS); its Payment Initiative also works on holdbacks and payment frequency (SCRS).

What matters more than any single invoiceable?

Enrollment. Invoiceables recover costs; enrolled patients generate the per visit revenue that makes a study profitable. A study with a perfect invoiceables list and two patients still loses money.

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Sources

  1. Society for Clinical Research Sites, Site Invoiceables Toolkit
  2. Society for Clinical Research Sites, Site Resource for Invoiceables (2022)
  3. Johns Hopkins School of Medicine, Standard Costs and Fees for Sponsored Clinical Trials (FY2024)
  4. LSU Health New Orleans Clinical Trials Office, Budget Development training
  5. St. Luke's University Health Network, clinical trial budget template
  6. Society for Clinical Research Sites, Payment Initiative

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