Evaluating Budgets

A successful clinical trial will include a budget that adequately meets the financial needs of conducting a trial. Since costs vary across the nation for supplies and services, budgets are almost always negotiable.

Sponsors usually use one of two options when presenting a budget. They may offer a certain amount per patient and ask that you work within that amount or they may ask you to formulate a budget for them. Regardless, it is your responsibility to ensure that the amount agreed upon will adequately cover all costs associated with conducting a clinical trial.

If you would like, you may fax, email or send a hard copy of your proposed budget along with a copy of the protocol to OCT for review. You will be provided with advice and recommendations to ensure that the budget meets your needs.

Required costs

Facilities & Administrative (F&A) Costs

According to the University policy, studies meeting the definition of a clinical trial are subject to the standard University Facilities & Administrative (F&A) cost rate. For fiscal year 2012, this rate is 28%.

Continuing Rates beginning Fiscal Year 2012

Effective July 1, 2012, the rates applied to industry funded clinical trials will be:

  • Off Campus adjacent, 28%. Adjacent rate applies to trials conducted in UNC Hospitals, CTRC and satellite offices within a ten-mile radius of campus (i.e. Highgate Diabetes Clinic)
  • Off Campus remote, 26%. Remote rate applies to trials conducted at sites outside of the ten-mile radius (i.e. Wake County Health Department)

Please note that retrospective research, data registries, etc. do not meet the clinical trial definition and therefore are not eligible for the clinical trial rate.

Typically, F&A costs are not waived for industry sponsors. To do so would force the university to subsidize the performance of sponsored research with university dollars for a for-profit corporation. See the university policy on F&A costs.Requests for reduction or waiver of F&A costs must be sent to the Associate Vice Chancellor for Research. View a list of all documents related to F&A.

Please ensure that ALL fees and other costs, including ALL invoiceables (except the IRB and BCA fees) include F&A costs. This includes CTRC fees and all invoiced costs such as MRI’s, EKG’s, advertising, etc. For example, the sponsor will reimburse the P.I. $1,000 for an MRI required by the protocol. Divide the total amount by 1.28 to determine the amount you will have remaining to pay the fee after F&A cost rate is applied.

>The Office of Clinical Trials will invoice industry sponsor separately for IRB and BCA Fees and department will be responsible for payment if there is nonpayment and the Fees are not specifically itemized in the sponsor budget.  These fees are payable upon IRB review and BCA conduct respectively, and should not be included in per patient amounts or embedded in other expenses.

For an overview of mandatory fees and related F&A’s in letter form that can be provided to a Sponsor, please see here.

Institutional Review Board (IRB) fee (not subject to F&A)

IRB Review Fee Policy, November 1, 2013

Background

The number and complexity of human research protocols at the University of North Carolina at Chapel Hill (UNC-Chapel Hill) have increased substantially in recent years. Each of these studies requires review and ongoing oversight by the Institutional Review Boards (IRBs), a process that is vital to the university’s ability to conduct such research. In the year 2000, the Schools of Medicine and Dentistry implemented an IRB review fee for new industry-sponsored protocols, as most peer institutions around the country had already done. Prior to this, the cost of overseeing industry-sponsored research was being subsidized by UNC-Chapel Hill. Even still, the IRB review fee offsets only a small portion of the costs related to this activity.

Beginning Oct 15th, 2013, the UNC-Chapel Hill IRBs began accepting IRB review from central/external IRBs for industry-funded, multi-site clinical trials where a central IRB had already reviewed the protocol. In these cases, the study sponsor often compensates the central IRB directly for their review. However, UNC-Chapel Hill is still responsible (and bears expense) for preparing the IRB package for the central IRB as well as for localizing consent forms for the proposed study. The UNC-Chapel Hill IRB will have an authorization agreement in place that allows for a central IRB to review, approve and oversee human subjects on behalf of UNC. When the UNC-Chapel Hill IRB cedes human subjects review and oversight to another IRB, UNC-Chapel Hill IRB maintains accountability for the compliance with all federal human subjects regulations and IRB determinations.

IRB Review Fee (not subject to F&A)

Effective November 1, 2013, UNC charges for IRB review of a single protocol are represented in the table below.

Industry-Funded Studies using a Central IRB Industry-Funded Studies using UNC’s IRB
Initial IRB Review Fee N/A $3,000
Initial Preparation Fee $1,000 Included in above
IRB Renewal Fee N/A $750

Applicability

These fees apply to all industry-funded human subjects research conducted by UNC-Chapel Hill, including sponsor-initiated and investigator-initiated studies. Excluded from the IRB review fee are human research protocols funded solely by federal or state agencies, non-profit foundations, or by departments/divisions/centers within UNC-Chapel Hill, where there is no industry funding. The fees will be added to the budgets of contracts that are entered directly with for-profit companies, as well as subcontracts issued to UNC-Chapel Hill from another institution.

Human Subjects Research Budgets

Sponsor contracts to be signed by UNC must include current IRB review and preparation fees in the study budgets. Additionally, the IRB review fees must be properly allocated in the internal budget required by UNC. The IRB review (and BCA) fees shall continue to be the only budget items exempt from the calculation of indirect costs (F&A), and therefore should be listed as  separate invoiced items.

IRB Review Fee Invoice and Collections Process

IRB review fees shall be incurred upon IRB review, even if a study contract has not yet been executed.  The IRB review fees are assessments for a portion of the real costs associated with protocol review and related study requirements by the IRB.  The actual costs of the review process are still incurred if subjects are never enrolled, if the study terminates before milestones are met, if expenditures exceed revenue, or if a contract is never finalized. The invoice is therefore due and payable upon receipt. Invoicing for IRB fees done by the Office of Clinical Trials. The investigator and/or department will be responsible for all costs not covered by the sponsor, specifically including the IRB (and BCA) review fees.

 

Billing Compliance (for conduct of BCA) fee (not subject to F&A)

A fee of $2,000 will be charged to the sponsor as a Billing Compliance Fee to cover the cost of conducting a BCA, and should be included in budgets submitted to the sponsor beginning March 1, 2014.  This fee is incurred upon conduct of the BCA, even if a study contract has not yet been executed. The Billing Compliance fee is invoiced by the Office of Clinical Trials separate from study start up costs.

In order to comply with federal, state and institutional regulations and standards for clinical trial billing, the University is responsible for establishing effective processes to ensure that all services for a study are billed properly. These processes can be complex because clinical trials often involve multiple entities that are responsible for costs incurred during the course of a trial. During a single visit a research participant may receive routine medical care in addition to services or procedures conducted purely for research purposes.

The purpose of the BCA is to determine deemed and qualifying status as well as which routine care costs may be billed to Medicare or other insurers and which costs must be paid by the sponsor. The Billing Coverage Analysis is required to be performed prior to the initiation of the clinical trial to ensure proper billing of services and financial feasibility.

 Contacts

For questions regarding:

– IRB Review and Coverage Analysis invoicing and applicability/ Policy – Christine Nelson, Director Office of Clinical Trials: 919-843-0832

– Contract negotiation – Nina L. Cannon, Director Office of Industry Contracting: 919-962-8531

– Questions regarding Coverage Analysis – Monica Coudurier, Project Manager Office of Clinical Trials: 919-843-2698

– Possible exceptions – Office of Sponsored Research: 919-966-2333

– IRB review (NON-FINANCIAL questions only) – Biomedical IRB: 919-966-1344

This Policy is maintained by the Office of Clinical Trials.

Investigational Drug Service fees (shall incur additional F&A)

When evaluating your budget, please remember that all investigational drugs must be stored and dispensed from the Investigational Drug Services (IDS) pharmacy.

Effective June 1, 2010, the IDS pharmacy began using a menu driven fee structure which includes both an initial set-up fee and monthly fees. A Protocol Intensity Worksheet will be used to score the intensity level (1-4) for each study protocol. A copy of the completed worksheet should accompany each Request for IDS Services. The Protocol Intensity Worksheet and Request for Investigational Drug Services form are available at: http://pharmacy.intranet.unchealthcare.org/services/investdrugs?searchterm=investigational+dr.

The initial set-up fee is billable when the request for a pharmacist to be assigned to the study is received prompting preparation of study records for dispensing. Monthly billing begins once the investigational product is received by the pharmacy and will continue for as long as the investigational product resides within the IDS pharmacy. Quarterly statements will be issued for the monthly charges. A summary of fees is shown in the table below.

Set-Up/Monthly Fee Annual Cost for Year 1 Annual Cost Subsequent Years
Level 1 $600/$42 $1,104 $504
Level 2 $1,000/$167 $3,004 $2,004
Level 3 $1,500/$292 $5,004 $3,504
Level 4 $2,000/$500 $8,000 $6,000

Please direct questions or concerns to Sue Pope at (919) 843-9919 or email at spope@unch.unc.edu.

It is expected that the pharmacy fees (plus applicable F&A) will be included in your budget.

Other costs

Trials require expenditures that aren’t always obvious. Include:

  • Copying
  • Long distance telephone calls
  • Overnight shipping
  • Faxes
  • Materials (paper, folders, gloves, etc.)
  • Long-term record storage
  • Specialty equipment

Time

Carefully examine the budget for the time requirements. Most protocols include a “schedule of events” which breaks down all study tasks required by the protocol.

Startup Time

All trials require a significant amount of time before enrollment actually begins. Consider time spent doing the following:

  • Site selection visit
  • In servicing staff
  • Investigator meeting
  • Setting up services with other departments
  • Site initiation visit
  • Protocol Review
  • Source document creation
  • IRB application
  • Regulatory documents
  • Informed Consent Form

Protocol Requirements

Translate the activity into a measure of time. For example, the schedule of events may list that vital signs are to be taken at each visit. How long does it take to complete a set of vital signs? Also, keep in mind the time required to draw blood. How long does a difficult blood draw take? How long will it take you to process and package the specimen? If you have to make telephone calls, estimate the time required. Consider worst-case situations. Also consider the time spent doing the following:

  • Recruiting
  • Scheduling visits
  • Explaining administration of a drug
  • Screening
  • Review of diaries
  • Consenting
  • Protocol specific procedures
  • Taking a history
  • Conducting a physical exam
  • Explaining the activities of the protocol
  • Pharmacy set up and dispensing

Day-to-Day Operations

The trial will require time outside of the protocol. Calculate the time you will spend actually running the trial. Include:

  • Communication with the sponsor/CRO
  • Maintaining the study file
  • Case Report Form completion
  • Monitor visits
  • Faxing documents
  • Resolving queries
  • Reporting Serious Adverse Events & IND Safety Reports

 

Payment Schedules

Sponsors will usually specify certain milestones that must be achieved before payment is made. Pay close attention to the timing and requirements of the milestones. Payment schedules may be appended to the contract as a table or may be written as a paragraph within the contract. Please see below for an example of a common payment schedule for a trial with 10 patients at $2500/subject.

Payment

Milestone

Amount

1 Initial Payment upon drug shipment $2500
2 After 3 subjects completed $7500
3 After 2 subjects completed $5000
4 After 2 subjects completed $5000
5 Final payment after all Case Report Forms are completed, queries are resolved and close out visit is complete $5000

A preferred payment schedule would be:

Payment

Milestone

Amount

1 Initial Payment (with IRB & BCA Fees invoiced separately) upon contract execution $6500
2 After 3 subjects randomized $7500
3 After 2 subjects completed $5000
4 After 2 subjects completed $5000
5 Final payment after all Case Report Forms are completed, queries are resolved and close-out visit is complete $2500

The Non-refundable Start-Up payment and the initial IRB and BCA Fees) should be payable upon execution of the Clinical Trial Agreement (CTA). The Non-refundable Start-Up payment is to cover the costs associated with trial set-up activities. Without the inclusion of a Non-refundable Start-Up payment and in cases when enrollment does not occur (i.e., no subject is ever randomized), no payment will be received and you will have incurred costs that will not be reimbursed. Instead, ask for a reasonable Non-refundable Start-Up payment that will cover your startup activities. This amount should be adequate to cover all costs incurred with initiating a trial including the IRB fee in the event that the trial never begins–often for reasons beyond our control.

Look at your milestone payment. Will you be paid on completion of Case Report Forms? That may mean waiting until the monitor has reviewed the CRF’s and sent them into data management or data clean-up completion. Will you paid on completion of a subject’s participation in the trial? This may delay payments. An ideal schedule will reimburse after a reasonable amount of subjects have randomized or after a certain number of visits are completed so that your study account does not run in a deficit.

Sponsors may also choose to hold back a significant portion of payment until all study activities are complete. Ensure that this is not an excessive amount. 10% of the total budget would be ideal and is fairly common across industry sponsors. Final payment may or may not depend upon waiting until ALL sites are closed or until the database has been closed. Pay close attention to this because it can mean that final payments may be delayed for an unreasonable amount of time.

An ideal payment schedule would include the following:

  • Non-refundable Start-Up payment that includes startup costs, and IRB and BCA Fees
  • Regular payments with realistic milestones
  • Final payment made upon closure at your site
  • Invoicing permitted for other costs (i.e. equipment, advertising)

Screen failures and early termination

Not every subject enrolled in a trial will complete the trial. Ensure that the budget and payment schedule provide for these circumstances adequately.