Budgets

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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?

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Reminders
 

• 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.