1. Clinical Trials – Industry Sponsored Budgets
ICTS Luncheon
Clinical Trials – Industry Sponsored Budgets
Ashley Tydon
Stern Center Business Manager
Chao Family Comprehensive Cancer Center

2. Gather information from the sponsor
Step by Step
Gather information from the sponsor
Protocol, IB
All manuals (Lab, Pharmacy, Imaging, Coordinator)
Central vendor questionnaires
Budget/Contract
FDA IND Acknowledgement

3. High-Level Protocol Review
Step by Step
High-Level Protocol Review
Use an Oncore Task List as a guide
Are there any interactions with a patient that will generate a charge in the hospital billing system?
Who is providing the drug/device?
What ancillary services will I need to use?
How many patients do we plan to enroll?
How long do we expect the study to be open to accrual and overall?

4. Collect Research Rates/Quotes
Step by Step
Collect Research Rates/Quotes
Request a calendar/MCA if necessary (this will generate all the hospital based research rates)
Requests reviews and quotes from all the applicable ancillary services (IDS, Radiology, Pathology, ICTS)
Sort out operational/logistical questions with your PI and CRC to determine the plan for who does what when

5. Time Estimated for Each Activity (hours)
Build your internal budget
Internal Budget identifies study costs based on labor costs and research rates for procedures.
Billing Grid
Add columns and rows to accommodate the # of visits, procedures and activities as defined in the protocol
Cycle
Screening
Cycle 1
Cycle 2
Cycle 3
FUP
# of
Per Patient
Study Procedure/Labs
CPT Code
Day
-28 1
30 days post
3 mo
occurences
Study Activities
Time Estimated for Each Activity (hours)
Total Hrs/Activity
Total Cost
ICF
0.00
$0.00
History/PE/PS
Con Meds
Adverse Events
ECG (supplied centrally)
Pregnancy Test
CBC w/ Diff
Coags
Archived Tissue Specimen
QoL
Drug Compliance
Total CRC Hours
CRC Per patient
0.00%
PI Oversight
PI Per patient
Data Manager
DataPer patient
Administrative
Admin Per pt
Total Salary

6. Negotiate your sponsor’s external budget
External budgets are negotiated with Industry Sponsors based on the Fair Market Value
The external budget must cover all the costs included in the internal budget. Leave yourself room to negotiate
Formats for sponsor budgets vary, as each sponsor requires their own format
The bottom line here is most important – don’t be afraid to get creative.

7. Helpful Hints Don’t forget about the payment terms!
Standardize your start-up and administrative fees to avoid haggling on big ticket admin items
Know your audience and be service-orientated
A word about fee for service (fixed price contract) agreements
Don’t take their first offer – sponsors expect you to negotiate
The power of the PI

8. Questions?