By Alexandra Opitz, Lead Clinical Research Analyst; Amanda Miller, Lead Clinical Research Analyst/Training Program Manager

Q: How do we get monitoring fees in the budget? It is hard to get sponsors to pay for monitoring. How do you charge for remote monitoring? Charging per page could be overwhelming.

A: We like to include monitor fees in every initial round of budget negotiations. If the sponsor removes it in the first round of negotiations, then we almost always push back and provide a detailed explanation of why the sponsor should pay for the monitoring visit. Additionally, cost documentation can be provided.

We typically charge an hourly rate for remote monitoring because per page is overwhelming and difficult to track. Many sponsors will not agree to an open-ended hourly rate, so we will put a cap on the number of hours. For example, $xx per hour up to three hours.

Q: Could you give us your input regarding the parameters that should be taken into account so that a more realistic and accurate budget can be planned?

A: There are several parameters that should be taken into account in order to develop an accurate budget.

Per patient budget: Time and effort items are budgeted using hourly rates for the physician, nurse, and/or study coordinator. Many sites pick average physician, nurse, and coordinator hourly rates to use for budgeting. It is also important to make sure that items with CPT codes are accurately budgeted. These costs typically come from a Chargemaster or Medicare rates. If a rate cannot be found in the Chargemaster or through Medicare, then it is important to obtain a cost quote for the item/service.

Administrative Fees: There are several administrative fees that can be included in a budget. At a minimum, every budget should include a start-up fee, an annual renewal fee, and a close-out fee. These three fees cover periods of the study where there is a heavy administrative burden on the site. The amount charged for these fees will vary by site and site structure. Be able to provide documentation and breakdown of how these fees were calculated. Many sponsors will request this information. If this information is not available, it is unlikely that the sponsor will pay the full amount.

Q: What suggestions do you have for renegotiating a portion of the budget?

A: First of all, do not be afraid to renegotiate portions of the budget. In order to renegotiate the budget, it is important to have justification of why an item should be added into the budget or a price should be increased. The justification can be as simple as a study required activity taking twice as long as expected and the budget needs to be updated to more accurately reflect the cost. If justification is provided, then most sponsors are amenable to renegotiating a portion of the budget. In our renegotiation experience, the sponsor/CRO has already seen similar requests from other sites. A common area for renegotiation is screen fails. If the sponsor caps screen fails, we often add language into the budget stating that after the screen fail cap is reached the site may renegotiate the budget to include additional screen failures.

Q: We have had difficulty negotiating to be reimbursed for subject screening activity. On some studies, we can spend multiple hours each week searching through patient charts that end up not enrolling in the study. Do you have any recommendations as to how to get this time reimbursed?

A: We recommend adding a pre-screening fee or chart review fee to the budget. We include language that states the fee is to cover time spent reviewing patient charts. The fee can be a flat fee per month or it can be an hourly rate up to a certain number of hours per week or per month.

Q: How do you handle sponsors that will not agree to pay for overhead on patient travel reimbursement?

A: A possible solution to this problem is to add a travel reimbursement processing fee to the budget that will be charged each time patient travel must be reimbursed. Some sponsors may not be able to accept overhead on the actual item, but may be able to accept a processing fee. Another option would be to increase the coordinator fee in the per patient budget to account for this activity.

If overhead is mandatory at your institution, then we recommend sending the sponsor the institution-wide overhead documentation. We work with several institutions that have their research overhead published online and the link can be easily provided to the sponsor/CRO.