Ashley Tydon Stern Center Business Manager Chao Family Comprehensive Cancer Center Step by Step Gather information from the sponsor Protocol IB All manuals Lab Pharmacy Imaging Coordinator ID: 646785
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Slide1
ICTS Luncheon
Clinical Trials – Industry Sponsored Budgets
Ashley Tydon
Stern Center Business Manager
Chao Family Comprehensive Cancer CenterSlide2
Step by
Step
Gather information from the sponsorProtocol, IB
All manuals (Lab, Pharmacy, Imaging, Coordinator)Central vendor questionnairesBudget/ContractFDA IND AcknowledgementSlide3
Step by
Step
High-Level Protocol ReviewUse an Oncore
Task List as a guideAre 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?Slide4
Step by
Step
Collect Research Rates/QuotesRequest 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 whenSlide5
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
FUP
# of
Per Patient
Study Procedure/Labs
CPT Code
Day
-28
1
1
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
0.00
$0.00
Con Meds
0.00
$0.00
Adverse Events
0.00
$0.00
ECG (supplied centrally)
0.00
$0.00
Pregnancy Test
0.00
$0.00
CBC w/ Diff
0.00
$0.00
Coags
0.00
$0.00
Archived Tissue Specimen
0.00
$0.00
QoL
0.00
$0.00
Drug Compliance
0.00
$0.00
Total CRC Hours
0.00
0.00
0.00
0.00
0.00
0.00
CRC Per patient
$0.00
0.00%
PI Oversight
0.00
0.00
0.00
0.00
0.00
0.00
PI Per patient
$0.00
0.00%
Data Manager
0.00
0.00
0.00
0.00
0.00
0.00
DataPer patient
$0.00
0.00%
Administrative
0.00
0.00
0.00
0.00
0.00
0.00
Admin Per pt
$0.00
0.00%
Total Salary
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
Slide6
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 negotiateFormats for sponsor budgets vary, as each sponsor requires their own formatThe bottom line here is most important – don’t be afraid to get creative.Slide7
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-orientatedA word about fee for service (fixed price contract) agreements Don’t take their first offer – sponsors expect you to negotiateThe power of the PI Slide8
Questions?