- Published
- Updated
- Sources checked
A signed agreement can still leave a protocol procedure unfunded or a reimbursement responsibility unclear. Reconcile the operational visit schedule with the site budget before the first participant is booked.
Separate research costs and care pathways
TİTCK application materials and good clinical practice provide the study governance context. Review the current local submission requirements alongside institutional contracting arrangements. A commercial payment term does not alter the protocol, participant information or responsibility for appropriate care, and it should not create an incentive to bypass eligibility decisions.
Build a procedure-to-payment map
We recommend a procedure-to-payment map listing each scheduled and conditional activity, performing unit, cost owner and documentary trigger. Include screen failures, unscheduled safety visits, pharmacy work and close-out tasks. Keep assumptions visible so a revised visit schedule can be assessed without rebuilding the budget from email history.
Check assumptions before signature
- Match every protocol visit and conditional procedure to an operational provider and cost owner.
- Reconcile participant expense statements with the agreement and consent materials.
- Define invoice evidence without unnecessary disclosure of identifiable participant information.
- Record amendment, extension and early-termination assumptions before final agreement approval.
Control later budget changes
When the protocol changes, review the map before issuing a budget variation. Record the effective scope and any unresolved treatment of earlier visits. Preserve investigator independence and distinguish payment verification from clinical judgement or the assessment of protocol compliance.
Frequently asked questions
- Does a fixed per-participant fee cover every scenario?
- Only if its documented scope addresses the planned and conditional activities; check the assumptions.
- Should invoices contain participant names?
- Use proportionate coded evidence and the authorized verification process rather than unnecessary identifiable data.