Direct Costs

Your study cost budget should include the role and estimated amount of “effort” to complete all study deliverables.  In determining “Effort” it is helpful to keep in mind that you are distributing a monthly salary amount regardless of how many hours are worked in that month.  (Note:  assuming the team member is not eligible for overtime pay.) 

For example:

1. A salaried team member worked 100% on a particular study and is paid $3,500 per month

2. Month One:  they worked 40 hours per week for the month 

3. Month Two they worked 50 hours per week for the month

4. The expense to the study for each month would be the same 

This would suggest that a reasonable approach would be to keep it simple by estimating the number of hours the activity will take, and ignore the overtime variable.  In the above example, 100% of the team member’s salary is allocated to a single study regardless of how many hours were worked.     

It is acceptable to either average a study team’s effort over all of the visits, or estimate the effort for each individual visit.  Don’t forget to include the time it takes for the study team member to prepare for and document the visit in addition to the actual time the visit will take. 

To create an on-going environment/process for quality review, it is strongly suggested that a sample of these estimated times, be compared against actual time collected only on a test basis.


What is Included in Salary and Wages

Only salaries of University of Colorado Anschutz Medical Campus should be included. Non-CU Anschutz personnel should be included in either the Operating Expense of “Consultant” or Operating Expense of “Sub-award”. 

What about if our PI has both clinical services and project oversight activities on a trial – how should I account for these two different types of activities in my cost budget? 

The clinical effort – is really providing clinical services.  Clinical services are to go through CU Medicine for billing and also for proper tracking of the Base, Supplemental and Incentive components of the faculty compensation plan.  Therefore, this expense will generally be booked to the account code of 535207 – UPI/CU Med Physician Billings as a result of a CU medicine invoice. 

If the PI’s effort is for activities related to the management of the study (either protocol-related activities of subject-related activities), this effort should be booked via the CU payroll system, as part of the “CU Position Funding” functionality in HCM.  This expense will be booked to the salary and benefits account codes on the study’s speedtype.