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Information to Gather

  • Is the proposed payment schedule acceptable to all parties
    (or, if there is no payment schedule, do you wish to include one)


  • Have you identified sufficient activities to allow recovery of partial
    payments if a subject does not complete the full study?


  • Is the language with respect to the number of patients expected acceptable to you? For example, do they include a minimum number of patients that may eliminate their obligation to pay if not met?

  • Is there a written or implied obligation to amend the agreement for increases in enrollment past a certain number of patients?  Is this acceptable to you?

  • Have you distinguished department IRB preparation costs from IRB fees that will be charged by the IRB?

  •  Is there a holdback of more than 10% of the amounts payable reserved for the end of the study?  Is a higher holdback value acceptable?

  • Are there multiple holdbacks (i.e. 10% upon final report and 10% upon submission of a publication)?

  • Does your budget include applicable indirect costs?


  • Include sufficient startup funding to break even in the event no patients are involved.

  • Ensure that all of your costs are covered, including indirect, start-up, per patient and close-out, and that IRB fees are included in the correct amounts.

  • Complete coverage analysis, if required.

  • Ensure it is sufficiently clear that the project is fee for service vs. cost reimbursement. A statement to that effect in the budget is ideal.

  • Include applicable indirect costs and reference them appropriately.

  • Provide a payment remittance or invoicing address.

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