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Protocol Related Cost Budget
The Clinical Research Administration Office (CRAO) received a significant number of requests to standardize a list of protocol related events with a standardized definition/activities that included in each event. In working with departments across the campus, a standardized list was developed and added to the OnCore Charge Master with a “TBD” (To Be Determined) Rate.
As a result, the protocol related portion of a study’s CU Anschutz cost budget can be completed in OnCore by selecting the appropriate events from this standard list and assigning the rates you have calculated when you completed the annual costing review of your protocol menu.
To provide for continuous quality improvement, it is strongly recommended that time required to complete these events be tracked on a sample of new studies throughout the year. The time samples that are collected throughout the year should then be used to refine the prices for each protocol related events. OnCore does have a time collection module that can assist with this collection of the required time.
The complete list of standard Protocol Related Events contained in the OnCore Chargemaster can be found here.
The definition of each Protocol-related event consists of the activities and related consumed supplies and services. As a result, a definitional table has been compiled to provide examples of the types of activities in each event. This definitional table can be found here.
This table includes the Charge Master Events in the first column at the left under the heading of “Study Lifecycle Phase”. It also provides a “Budget Tool Grouping” which is at a bit more detailed level, if you choose to use it. As you move from left to right, the template provides activity examples that are included in each of the Charge Master Events/Study Lifecycle Phase. Further to the right the template provides columns to include services and supplies that should be included in the price and also a column for estimated time it takes to complete the event.
Each Study Lifecycle Phase is broken out between the “Base” and “Add-on’s” and “As-Incurred” in the case of the Maintenance Lifecycle. The Base should include those activities that will be required for all protocols. The Add-on’s should include the cost of those activities that are required only by certain protocols. For example, not all protocols will require radiology services. As a result, the cost of these activities is included as an add-on to the base.
Please remember to include benefits and salaries for each study team member when extending the estimated number of hours to arrive at the estimated direct cost. Also, don’t forget to add F&A to all events and an inflation factor for the maintenance and close-out events. The calculations for the inflation factor are provided in the “Inflation” portion of this website. To calculate rates for each standard Protocol Related event, identify the following items:
| Standard Pricing Events | Activity Examples | PI Hours | Study Coordinator Hours | Financial Staff Hours | Total Effort Costs | Supplies Purchased | Services Purchased | Total Direct Costs |
| IRB and Other Regulatory Submissions and Reviews | Determine which IRB will be used, compile required documents | 2 | 20 | 1,200 | 3,500 | 4,700 | ||
| Resolve questions from IRB and ensure approval is obtained | 5 | 250 | ||||||
| Radiology Protocol Startup Review required? | 800 | 800 | ||||||
| Protocol Pathology Startup Review required? | ||||||||
| Scientific Review required? | ||||||||
| Total for IRB and Other Regulatory Submissions and Reviews - Direct Costs | 2 | 25 | 0 | 1,450 | 0 | 4,300 | 5,500 | |
| F&A at 28% | 406 | - | 1,204 | 1,540 | ||||
| Total for IRB and Other Regulatory Submissions and Reviews - Total Costs | 1,856 | - | 5,504 | 7,040 |
Note: More than one rate can be calculated for each of the events above. If your department has studies that vary significantly as to the amount of effort it takes to complete each of the tasks above, you may want to consider to establish rates for (1) and observational study, (2) a simple protocol, (3) an average protocol (4) a complex protocol and/or perhaps even a (5) Investigator-Initiated Trial (IIT).
In addition, you may also include an inflation factor for the “maintenance” and close-out rates since these activities will occur more than in just the current year.
The endpoint of these calculations will be a “menu” that you can use repeatedly for each new protocol that you work on. It is recommended to review your calculated rates at least once a year to determine if they are still reasonable in amount.
OnCore contains each of the above Events in the internal Charge Master. Each of these will be set up in OnCore with a “TBD” price so that you can load the rates you have calculated above. This rate will become the amount the sponsor is charged, so be sure that you have included F&A on all events and an inflation factor for the maintenance and close-out events in the calculation of your rates.
Clinical Research Administration Office (CRAO) also has available an Excel Workbook that can be used to help calculate these Protocol Related Events.