Sponsored Program Compliance

Timing of Reimbursement

The negotiated terms for timing of reimbursement are as important as the amount being negotiated. The reimbursement terms should correspond (as closely as possible) to the incurrence of costs. The UR should not be asked to effectively extend credit to the trial sponsor. When case report forms impact the ability to be paid, negotiate payment terms based on case report form submission, not based on the occurrence of monitoring visits.

Negotiate reimbursement of costs to be incurred even if there is no enrollment (e.g. pharmacy maintenance fee, recruitment costs, screen failures, meetings, et cetera).

Often sponsors require financial terms that specify a “holdback” on payments until the final close out of the trial (at which time the holdback is paid). Holdbacks of no more than 10% are generally acceptable if a sponsor insists on such a provision.