The first step in budgeting costs of a protocol (both protocol-related/management events and subject-related/management events) is identifying all of the activities required to be performed in order to complete the study.
The following has been discussed in the webpages:
2. What are CU Anschutz’s Main Activity Categories? (This Section/Page)
The second step is estimating direct costs for each of these activities. Each activity’s cost is estimated by answering three questions:
1. How much effort will it take to complete the task by all study team members?
2. What services must be purchased to complete the task?
3. What supplies must be purchased to complete the task? Once these questions are answered, then the estimated direct cost for each activity can be determined by:
Once these questions are answered, then the estimated direct cost for each activity can be determined by:
1. Effort = estimate number hours and multiply by study team member’s base salary plus benefits and fringe
2. Purchased services = pricing from UCHealth, CU Med, CCTSI, CU Anschutz Service Centers, etc. for services they provided. There can be other services such as shipping costs to ship lab samples to a central lab.
3. Purchased supplies = estimated costs to purchase lab supplies, sample shipping supplies, etc.
As an example (for a Protocol-related activity), the following might be a component of your Start-up cost budget:
|Standard Pricing Events
|Study Coordinator Hours
|Financial Staff Hours
|Total Effort Costs
|Total Direct Costs
|Total UCD Cost
|IRB and Other Regulatory Submissions and Reviews
|Determine which IRB will be used, compile required documents
|Resolve questions from IRB and ensure approval is obtained
|Radiology Protocol Startup Review required?
|Protocol Pathology Startup Review required?
|Scientific Review Required?
|Total for IRB and Other Regulatory Submissions and Reviews
The activities already identified are contained on the rows. Then the “three direct cost components” can be estimated under the column headings of Effort, Purchased Supplies, and Purchased Services. The sum of these three cost components will come to the Total Direct Cost for the activity.
These costs are known as “Direct Costs” because they are incurred as a direct result of completing the activity. The University would not have incurred an expense if the Clinical Trial study was being conducted.
Note: Facilities and Administration (F&A) is an indirect cost and discussed in the F&A portion of this Major Categories of Expense Types.