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INDUSTRY SPONSORED BUDGET WORKSHEET FOR RESEARCH COSTS BILLABLE TO WCMC RESEARCH FRS ACCOUNTS

*Do not include standard of care costs billable to the patient or his insurance company

Principal Investigator:______________________________________________________
Study Title:_______________________________________________________________
Sponsor:________________________________________________________________
Sponsor Protocol Number:_________________________________________________

Start Date:_________________________ End Date:______________________

WCMC INDIRECT COST RATE: 33%

RESEARCH SERVICES
I. PER PATIENT BUDGET
Study Time-Line Screening Visit Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 Visit 8 Visit 9 Total

Non-Procedures and Administrative Per Patient Activity Unit Cost


Informed Consent $ - -
Inclusion/Exclusion Criteria $ - -
Chart Review $ - -
Medical History $ - -
Adverse Reactions Reporting $ - -
Medication Dispensing/Returning (NYPH) $ - -
Medication Accountability (not NYPH) $ - -
Patient Stipend/Reimbursement* $ -
CRF Completion $ - -
SUB-TOTAL Non-Procedures $ - $ - $ - $ - $ - $ - $ - $ - $ - $ -

Clinical Procedures/Diagnostic Tests -


X rays & Scans -
ECG -
Out-patient Tests/Procedures (itemize) -
In-Patient Tests/Procedures (itemize) -
Urine & Blood Workup -
CBC -
Other Tests/Procedures (itemize) -
SUB-TOTAL Procedures $ - $ - $ - $ - $ - $ - $ - $ - $ - $ -
-
SUB-TOTAL PER PATIENT COSTS $ - $ - $ - $ - $ - $ - $ - $ - $ - $ - $ -
Indirect Cost Rate @33% $ - $ - $ - $ - $ - $ - $ - $ - $ - $ - $ -
TOTAL PER PATIENT COSTS $ - $ - $ - $ - $ - $ - $ - $ - $ - $ - $ -

NUMBER OF PATIENTS 10
TOTAL PATIENT COSTS $ -

STUDY START UP COSTS INVOICEABLE COSTS

II. START UP COSTS INVOICED BY OCTA COST 33% IDC TOTAL OTHER FEES NOT INCLUDED IN THE PER PATIENT BUDGET

Institutional IRB Fee: $2000 (Non-Refundable) $ 2,000.00 NA 2,000.00 IV. Unit cost Frequency/ number 33% IDC Total Invoice
Protocol Review Fee (if applicable) - - Screening Failures 5 $ - $ -
Scientific Review Committee (if applicable) - - Optional CAT-Scan 1 $ - $ -

Non-Refundable Administrative Start Up Fee* (calculate using Time Other invoiceable patient clinical
& Effort Tab) - - procedures (insert rows as needed) 1 $ - $ -

Pharmacy Set Up & Storage (Obtain actual fees from NYPH Patient travel reimbursement (if not
Research Pharmacy) - - included in the per patient budget) 0 $ - $ -
Other: - - - Monitoring Visit 4 $ - $ -

TOTAL STARTUP COSTS $ 2,000.00 $ - 2,000.00 Follow-up Unscheduled Visits 5 $ - $ -

FDA Audit Fee 2 $ - $ -

Regulatory Fee - For processing


III. OTHER STARTUP COSTS TO CONSIDER COST 33% IDC TOTAL continuing review 1 $ - $ -
Amendment/continuing review
PI Travel - - submission 1 $ - $ -
Site Training - - Querie Resolution 4 $ - $ -

Advertising NA - Telephone calls 7 $ - $ -


TOTAL INVOICEABLE
Postage - - COSTS $ - $ -
Dry Ice - -
Consent Translation fee - -
Study Start Up Bonus - -
Record Storage - -
TOTAL OTHER COSTS $ - $ - $ -

I. TOTAL PATIENT COSTS $ -


II. STUDY START UP COSTS $ 2,000.00
III. OTHER START UP COSTS $ -
IV. INVOICEABLE COSTS $ -

TOTAL CONTRACT VALUE $ 2,000.00

The Office of Clinical Trials Administration will invoice the sponsor for the start up costs included in section II. The PI/Department is responsible for invoicing the sponsor for all other study activity according to the payment schedule negotiated in the clinical trial agreement.
NOTE: This budget template is blank. You may contact OCTA at OCTA@med.cornell.edu for a sample budget
This document is meant to aide in the process of conducting a clinical trial and its usage is not required, for it is not part of the formal procedure conducted at WCMC.

9/23/2010 Copy of CT budget 7/18/05