Clinical Trials Budget Worksheet Instructions

Purpose

The primary purpose of this tool is to compare, in detail, the site costs for implementing the study with the sponsor reimbursement. Any costs that are not being reimbursed by the sponsor must be identified along with a funding source (i.e., the site department). Use of this specific tool is optional. You may create your own form as long as the information fulfills the purpose stated above.

How to Use this Worksheet

Fill in your site costs using suggested examples and any other line items that fit your unique protocol. The summary column will auto fill with most of the information requested except your estimated total recruitment which you will need to add. Additional rows may be inserted as needed. Note that you may need to identify a larger number of patients to pass a certain protocol point in order to get to the desired end number. For example, you may incur the cost of completing 60 screen visits in order to randomize 30 subjects. At the bottom of the form complete the total site reimbursement from the sponsor and attach your sponsor budget (usually part of your Clinical Agreement). Explanations of discrepancies between site costs and sponsor reimbursement, including donations of time and funds from other sources (such as the site department) should be noted in the Resources and Expenses section under Scientific and Merit Review in the Research Application.

Per Patient Costs

All items listed in these categories should be associated with a specific patient visit. Following are some examples:

Procedure or Task

Medical history, physical exam, vital signs, x-rays, quality of life and other questionnaires, adverse experience monitoring, diet counseling, medication compliance assessment, ECG, EMG, mental status tools, case report form completion

Laboratory

Venipuncture, sample processing costs, on-site specimen testing, laboratory department charges

Pharmacy

Pharmacy department reimbursements for dispensing, purchase of products from Pharmacy, preparation charges

Other per/patient Costs

Subject travel reimbursement, stipends, parking, per person supplies such as thermometers

Other Study Costs

These costs are associated with activities that occur throughout the study and not necessarily at specific protocol visits. It is likely that these costs are the largest percentage of the total cost to implement the protocol.

Personnel

Start-Up activities such as Investigators' Meeting, site initiation visit by sponsor, ongoing monitoring visits and preparation for them, ongoing IRB communications and reports, design of internal process and forms (such as source documents), staff hiring, investigator time, team meetings, recruitment activities, financial management, subject management including follow-up phone calls, subject scheduling, locating subjects lost to follow-up, coordination with other departments, training of research and non-research staff, resolution of data queries, project archiving

Misc.(Fax machines, cell phones, etc.)

Newspaper and radio ads, purchase of project-specific equipment such as fax machines, freezers, software, PDAs or cell phones, phone and fax costs, brochure or subject information printing costs. Advertising costs are noted on pg 2 rather than here (they are not included in indirect cost calculations).