Budget Development

1
Budget Development

• Presented by
• Jean Mercer
• Associate Director for Clinical Research
  Administration
• Office of Clinical Research School of Medicine

2
Topics that will be covered

• Systems for budget development.
• Identifying items to budget.
• Standard of care items.
• Identifying pricing information.

3
More Topics

• Indirect costs
• Start up expenses
• Screen failures
• Budget feasibility

4
Systems for Budget Development

• Study Manager
• Contact Karen Best (8-5850) for training
• Excel Spreadsheet

5
How do I identify what items I need to budget?

• Review the Schedule of Activities spreadsheet in
  the protocol.
• Review the Study Procedures section of the
  protocol.

6
Identifying Items to Budget

• Review the budget exhibit or section of the
  contract agreement.
• Talk with the Research Coordinator (if
  applicable) who will be involved with the study.

7
What about Standard of Care Items?

• As you review the protocol look to see what tests
  and procedures may be considered Standard of Care
  for the patient population involved in the study.
• Identify these items as SOC on your budget
  spreadsheet.

8
How do I find the cost information for
procedures/tests?

• Contact the appropriate area to obtain pricing
  information. (See contact list)
• Use Study Manager to obtain pricing information
  for Clarian procedures.

9
Indirect Costs

• Do I really have to include these? (Yes ?)
• The current indirect cost rate for an
  industrially sponsored clinical research trial is
  25.
• The current indirect cost rate for a federally
  sponsored clinical trial is 33.5.

10
Commonly Requested Start Up Costs

• IRB Fee - 2,000 (only if industrially sponsored)
• IRB Submission Effort average is 1,500 -
  2,000
• Pharmacy Set Up Fee determined by
  Investigational Pharmacy.

11
Commonly Requested Start Up Costs (cont.)

• Administrative Start Up Fee average is 2,000
• Archival/Storage Fee storage of records after
  study has been completed. Average budget is
  750.
• Close out/Queries for Data Lock Average budget
  750 - 1,000.

12
Additional Start Up Fees

• Effort for nurse coordinator and PI to attend
  study start-up meeting hosted by sponsor.
• Effort involved for FDA Audit.

13
Non-Refundable Costs

• IRB Fee
• IRB Submission Effort
• Pharmacy Set Up Fee
• Administrative Start Up Fee
• Even if a study does not enroll any patients you
  need these basic costs covered.

14
Screen Failures

• Goal is to get at least the cost for the first
  visit covered if a patient does not pass the
  screening process.
• Many Sponsors want to pay a minimal amount for
  screen failures.
• Evaluate your study to determine if you expect to
  have several patients drop out.
• Negotiate with the sponsor on this number.

15
Budget Feasibility

• Is it feasible to conduct this trial with the
  current budget from the Sponsor?
• If it is not feasible, then what is the bottom
  line amount you must have?

16
Negotiating the Budget

• Find out who the contact is at the pharmaceutical
  company that you should work with.
• Send an email or call the contact person and
  introduce yourself.
• Send via email your detailed spreadsheet with the
  proposed IU budget and ask the Sponsor to review
  it.

17
Internal Budget

• IU requires that a brief internal budget be
  included when you route your contract.
• Example
• Direct Costs 25,000
• Indirect Costs 6,250 (25 IC rate)
• IRB Fee 2,000
• Total Costs 33,250

18
Routing of the Contract

• You can route your contract while the budget is
  being negotiated.
• Just note on the route sheet that the budget is
  not finalized yet.
• It is preferred that you use an ERA route sheet
  and attach the electronic files for the internal
  budget and contract.

19
QUESTIONS?

• Contact Jean Mercer
• Phone [phone]
• Email jemercer_at_iupui.edu