Education Module
Budget Development: Identifying Costs

Introduction

There are many costs to consider and identify when developing a budget for clinical research.  This module will review some standard costs to include when developing a budget.  It is important to note that these costs are not comprehensive – there will likely be other costs you will need to consider.

Developing a Budget

When developing a budget, consider the following:

1. Identifying items to budget
2. Standard of care items
3. Indirect costs
4. Start-up expenses
5. Screen failures
6. Budget feasibility

Identifying Items to Budget

In identifying items to budget, first review the Schedule of Activities spreadsheet in the protocol.  The Study Procedures section of the protocol should also be reviewed, as should the budget exhibit or section of the contract agreement.  It is important to discuss items that will need to be budgeted with a research coordinator (if applicable) who will be involved with the study.

Standard of Care Items

As the protocol is reviewed, determine what tests and procedures may be considered Standard of Care (SOC) for the research participant population.  These items should be identified as SOC on the budget spreadsheet.

Indirect Costs

It is important to include indirect costs when developing a budget.  The indirect cost rate for an industry sponsored clinical research trial is typically 25%, but may vary by institution.  Always check with your institution to determine the indirect cost rate.  The indirect cost rate for a federally sponsored clinical trial is determined at each institution.  It is important to note that some foundation grants provide no indirects.  National Institutes of Health grants and international grants typically give an 8% indirect cost rate.

Start-up Costs

Some commonly requested start-up costs include the following:

1. Institutional Review Board fee – typically $2,000 (only if industry sponsored)
2. Institutional Review Board submission effort – average is $1,500-$2,000
3. Pharmacy start-up fee – determined by investigational pharmacy
4. Administrative start-up fee – average is $2,000
5. Archival/storage fee – this includes storage of records after the study has been completed; average is $750
6. Close out/queries for data lock – average is $750-$1,000

Note: National Institutes of Health budgets are set up very differently.

Budget Feasibility

When developing a budget, ask yourself the following questions: (1) is it feasible to conduct this clinical trial with the current budget from the sponsor?; and (2) if it is not feasible, what is the total amount needed to conduct the clinical trial?

Other Tips

A budget should always be developed in close discussion with a mentor or advisor.  It is often useful to review other budgets from a similar grant or clinical trial to ensure important items are not being omitted.

Question & Answer

This question and answer section is designed to test your knowledge of audits in clinical research.  Answers are provided so that you can ensure you know the right answer.  No credit is given for completing these questions.

Question 1
Question: How do you determine whether an individual should be listed as a consultant or an investigator?
Answer: Institutional policy should be referred to for this.  For differences between sub-awards and consultant agreements at Brown University, see: http://research.brown.edu/rschadmin/faq_subaward.php.  Putting a budget together is always complicated and touches on multiple issues.  It is important to have a knowledgeable mentor of colleague to consult on these types of issues.

Acknowledgements

This module was adapted from a power point presentation available at the Indiana Clinical and Translational Sciences website.  The original power point is available at: http://www.indianactsi.org/coordinators/pastmeetings.