Frequently Asked Questions

The estimated Direct Cost of an activity is the sum of:

• Estimated amount of time to perform the task extended by salary and benefits
• Any supplies consumed in the performance of the task
• Any services consumed in the performance of the task

Only activities that are required in order to complete the study’s scope should be included. Activities/expenses that may only enhance the department’s ability to complete the study are not appropriate to include.

For example, if a laboratory staff is completing a course on Good Clinical Practices at the time the study is starting, in most circumstances, it should not be charged to the study. This type of training will certainly enhance/benefit the outcome of the study and is required to properly work in a lab on any study. However, it is not specific to complete a particular study’s scope of work. Therefore, it would – in most circumstances – be more appropriate to charge this training to a non-fund 30 speedtype.

Direct Costs are those expenses that are incurred as direct result of completing the study. These expenses would not be incurred if the study was not being done. Examples include salary and benefits of the study team for the amount of time they work on the study in either Protocol Related Activities or Subject Related Activities.

Indirect costs are expenses incurred by the University whether a particular study is being worked on or not. These include the expenses associated with having buildings available and operational (utilities and maintenance) as well as central administrative services such as leadership and central offices salaries/benefits, central computer systems like payroll, purchasing, accounts payable, email, etc.

Adding Indirect Costs to Direct Costs brings you to Total Costs

No, these two categories of events/activities have separate process flows in OnCore and in Sponsor Invoicing:

The Standard Protocol Related Events follow the life-cycle of a study: Start-up, Maintenance and Closer-out. To provide the needed flexibility to accommodate the various types and complexity of studies, each life-cycle phase is broken out in to the:

Base – the costs of those activities that are completed for every protocol. For examples IRB submission.

Add-on’s – additional activities that can be added to each protocol only if needed. For example, not all studies will use a pharmacy, so the pharmacy start-up fee would be an add-on to the start-up base only for those studies using a pharmacy.

In the case of the Maintenance life cycle phase, the add-on’s are split into two groups to leverage OnCore functionality for sponsor invoicing. In addition to the add-on’s group, a second group called “as-incurred” is also available in the Maintenance life cycle.

The difference between these groups is that the add-on group occurs on a set schedule so that it is known when to invoice the sponsor. The as-incurred group events can happen any time. As a result, the study team has to let the billing team when a particular event happened. This can be completed in OnCore by the study team using the “CRA trigger” to create the invoiceable item.

The Standard Protocol Related events matrix with only a few events for illustrative purposes looks like:

View the entire list (and definitions)

A centrally-used calendar with subject-care costs is available in OnCore. Once this calendar is completed in OnCore and reviewed by the study team, it can be exported into Excel where the following cost components can be added:

• Study team time using salary and benefits in the rate
• Other Direct Costs other than subject care. Examples include subject stipends, travel, lab supplies, misc. expensed lab equipment not provided by the sponsor, etc.
• F&A/Indirects
• Inflation Factors
• Contingencies

Go to the “Financials Module”, search and find your protocol. The screen returned will be the “Parameter” page that displays basic financial information used in several other screens within the financial module. Locate from the left-hand column the link for the “Subject Related”. The resulting page will contain all of the procedures in list format. Located at the bottom right-hand corner of the “Subject Related” page is a button labeled “Budget Calendar”. Clicking on this button brings you to a pop-up that allows you to select the calendar and budget version to be used in the requested calendar. Once selected, OnCore reformats the procedures into a calendar format.

The Budget Calendar also has various filters available to you. One of the most important is to choose the “Use Cost”. The value will default to “Negotiated”, but “Research” is also an option. Once the cost base is selected you can export the subject care costs calendar into Excel by clicking on the “Export to Excel” button at the bottom of the left-hand filter list.

The Budget Calendar page looks like:

Go to the Financials module and search for a protocol. Once the protocol is found, click on the “Subject Related” from the left-hand column of tabs. The resulting page consists of two sections.

The first section contains a list of all the procedures that are called “events” in Oncore. These events are the parents in a parent/child relationship.

The second part of the page contains the children for each event contained on the first section. These children are called “items”. So, in Oncore an event (parent) is made up of items (children). In the case of a procedure that has both a tech and pro fee, the event (parent) will display in the top of the screen with the costs summed.

In the second part of the screen, the tech and pro fees (items/children) are listed separately with the cost of each also listed separately.

An example of a list of events on the top portion of the page:

An example of the lower portion of the screen listing the items for each event:

No. Clinical services provided by a PI or any other Faculty member on the study will be billed to the study through CU Medicine using CPT codes just like UCHealth. Therefore, this time/services will be included in the Subject Care Costs contained in the OnCore cost budget – i.e., Budget Calendar that is exported from OnCore in the cost budgeting process.

The PI’s/faculty member’s time spent on managing the study, protocol, study team, sites, etc. also needs to be budgeted and charged to the study. This component of the PI/faculty’s estimated time should be included alongside the other study team’s time on both protocol-related and subject-related events. The salary expense for these types of activities will be charged to the study via CU’s payroll system.

The salary amount for faculty members time only applies to those activities completed to manage the study, protocol, study team, study sites, etc. Remember, the cost for clinical services are included in the “Pro Fee” CPT codes contained in the subject care costs exported from OnCore.

Like Federal awards, the faculty member’s incentive pay (if one is included in their compensation) should be excluded from the salary rate used to be included in the cost budget. Only the faculty member’s base pay should be included. Using the terms of the CU payroll system, any “Rate Code” that starts with “BASE” or “BAS” should be included.

Some common examples include

• BASEM for Base, monthly
• BASSUP for Base, supplement (as defined in the faculty compensation policy)
• BASADM for Base, administrative supplement

These amounts can be found on the “Compensation” tab of the HCM system.

In addition to the above amount, benefits and fringe should also be included in calculating the cost for faculty member’s time on the study.

Yes – fringe is different and in addition to Benefits. These expenses do not apply to all job codes. The applicable job codes can be identified by reviewing the “Fringe Benefits Matrix” on the Finance Website. If applicable, the fringe includes:

1. Worker’s Compensation
2. Unemployment Compensation
3. Termination Pay
4. Retiree Health, Life, and Supplemental Annuity

Indirect Costs (F&A) are calculated by multiplying some or all of Direct Costs by a defined percentage.  Both the percentage and the costs this percentage is applied to are defined by the type of research being conducted and the sponsor’s business entity type.

For industry-funded human subject research, the F&A rate/percentage is 28%.  This percentage is applied on Total Direct Costs (the basis). 

Other rates and basis

For subject-related costs and maintenance protocol-related events, the current cost per the OnCore chargemaster and the calculated future amount are averaged. The future amount can be calculated one of two ways: View examples of these calculations

For the protocol-related close-out rates, only the future value should be used. The CRAO protocol-related events template has these calculations built-in.