Protocol Management Activities and Costs
Protocol-related activities include those activities that are completed to manage the protocol. It includes activities such as:
1. IRB submission
2. CU Anschutz Costs Budget preparation and negotiation
3. Coordinating pharmacy review and set-up
4. Financial review and close-out of the speed type
It does not include activities related to the scheduling of, completing and documenting the study subject visits.
Most activities related to the management of the protocol can be identified by walking through the life cycle of the study – excluding the subject management activities - with each participating study team member. Discuss topic such as:
1. What does each study team member do to get the study ready to accept the first subject enrollment? (Start-up Phase)
2. What does each study team member do to keep the study current with the protocol and open to enrollment? (Maintenance Phase)
3. What does each study team member do to properly close the study? (Closeout Phase)
Some activities are required for all protocols, and other activities are applicable on a protocol-by-protocol basis. As a result, activities within each life-cycle phase can be broken down into the “Base” activities and “Add-on” activities. The Base will include those activities that are required to be completed for all protocols. The Add-on can be selected to fit each protocol.
In addition, not all Add-on activities can be scheduled, i.e., some Add-on activities are triggered by something other than time. As a result, Add-on Maintenance activities have an additional group of activities called “As-Incurred” activities. This further breakdown leverages functionality in OnCore that allows study team members to mark “As-Incurred” events as occurred and make this event available to the Post-award team for inclusion on an invoice submitted to the funding sponsor/CRO.
| This breakout can be summarized: | |
| Base Scheduled Activities |
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| Add-on Scheduled Activities |
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| As-Incurred Activities |
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Step two in completing the cost budget is to estimate the expense amount all of the direct costs associated with each activity:
1. Effort
2. Purchased Supplies needed to complete the activity
3. Purchased Services needed to complete the activity For example, the effort, services and supplies for once piece of the study set-up could look like:
| 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 | ||||||
| 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: For Industry-sponsored and Non-Federal clinical trials, F&A will be charged on all direct expenses. As a result, F&A should be calculated on the sum of all direct expenses. In addition, an inflation factor should be included for Maintenance and Close-out components of your Protocol Related Events. Please see the “Finishing Touches” for assistance with how to calculate and add the inflation factor into these events.
Bringing back our endpoint: Completion of these two steps for Protocol-related events would now fill out the highlighted portion of the Total Direct Costs Grid:
| Budgeted Amounts | Effort | Purchased Services | Purchased Supplies | Total Direct Costs |
| Protocol Level: | ||||
| Start-up Base | $ | Lab Supplies | Total direct startup costs | |
| Start-up Add-on One | $ | Perhaps UCH Pharmacy | Total direct startup add-on's | |
| Maintenance - Base | $ | Total direct maintenance costs | ||
| Close-out Base | $ | Total direct close-out costs | ||
| Note: Pass-throughs would be listed for each study - for example, small equipment | ||||
| Subject Level: | ||||
| Visit 1 | $ | UCH patient care | Copies of questionnaires | Total per visit direct costs |
| Visit 2 | $ | UCH patient care | Total per visit direct costs | |
| Screen Failure | $ | Labs | Total Screen Fail direct costs | |
| Total Effort | Total Operating Expenses - Purchased Services | Total Operating Expenses - Purchased Supplies | ||
This Protocol endpoint can also be thought of as a “Menu” where we pick the appropriate “activities” for a particular study. Since the time it takes to complete these activities may vary with the complexity of studies, budgeted total costs can be developed for a simple protocol, another budgeted cost amount for the average protocol, and perhaps a third for a complex protocol.
Another option, if it fits better for your department, is to perhaps have only average and complex budgeted costs. These are just options that would provide more flexibility across departments while using a standard list and definition of activities.
| Protocol Level Study Lifecycle Phase | Standard Pricing Events | Registry/Observational Study | Industry IND - Simple Protocol | Industry IND - Average Protocol | Industry IND - Complex Protocol | IIT |
| Base | $ | $$ | $$$ | $$$$ | $$$$$ | |
| Administrative and Financial Startup | ||||||
| Investigational Product Startup | ||||||
| Subject Recruitment Planning | ||||||
| Study Management Setup and Activation | ||||||
| Planning and Regulatory/Financial Setup - Add-on's | IRB Review Preparation, Submission and Approval | $ | $$ | $$$ | $$$$ | $$$$$ |
| Pharmacy Start-up | $ | $$ | $$$ | $$$$ | $$$$$ | |
| Radiology Set-up | $ | $$ | $$$ | $$$$ | $$$$$ | |
| ICF Translation Fees | $ | $$ | $$$ | $$$$ | $$$$$ | |
| Study Maintenance - "Annual" Charge - Base | $ | $$ | $$$ | $$$$ | $$$$$ | |
| Administrative and Financial Maintenance | ||||||
| Investigational Product Maintenance | ||||||
| Subject Continuing Recruitment | ||||||
| Study Documentation Management | ||||||
| Study Maintenance - "Annual" - Add-on's | IRB and Other Regulatory Maintenance Submissions | $ | $$ | $$$ | $$$$ | $$$$$ |
| Pharmacy "Periodic" Review Fee | $ | $$ | $$$ | $$$$ | $$$$$ | |
| Radiology "Periodic" Review Fee | $ | $$ | $$$ | $$$$ | $$$$$ | |
| Study Maintenance - "As-Incurred" | Sponsored Monitoring Visits | $ | $$ | $$$ | $$$$ | $$$$$ |
| Change in Sponsor/CRO Agent | $ | $$ | $$$ | $$$$ | $$$$$ | |
| Change in Key Study Personnel | $ | $$ | $$$ | $$$$ | $$$$$ | |
| Protocol Amendments | $ | $$ | $$$ | $$$$ | $$$$$ | |
| Translation Fees (per hour) | $ | $$ | $$$ | $$$$ | $$$$$ | |
| Safety Report | $ | $$ | $$$ | $$$$ | $$$$$ | |
| Total Study Closeout Charge - Base | $ | $$ | $$$ | $$$$ | $$$$$ | |
| Administrative and Financial Closeout | ||||||
| Investigational Product Closeout | ||||||
| Subject Closeout | ||||||
| Final Study Results and Reporting | ||||||
| Study Close-out - Add-on's | IRB Closeout | $ | $$ | $$$ | $$$$ | $$$$$ |
| Pharmacy Closeout Fee | $ | $$ | $$$ | $$$$ | $$$$$ | |
| Radiology Closeout Fee | $ | $$ | $$$ | $$$$ | $$$$$ |
A final thought on protocol related cost budgeting is that once you have completed the budgeting for your department, for all of the usual varieties of clinical trials, the above “menu” can be used to pull the CU Anschutz’s Cost Budget for the events that pertain to a specific trial. Unlike the Subject-related events, the Protocol-related amounts do not need to be recalculated for each new protocol.
The Protocol-related estimated costs may be reviewed once a year to ensure the budgeted costs are still reasonable. To complete this review, it is recommended to ask team members to track actual time spent on the various activities in your worksheet on a few (not all) of actual studies during the year and compare these “actual” data points to your budget and make any necessary adjustments. This process can be used annually to provide a quality review and continuous improvement feedback loop for the protocol related budgets.