Description *RC/S/V Unit amt Screening C1 D1 C1 D15 C2 D1 C2 D15 C3 D1 C3 D15 C4 D1 C4 D15 C5 D1 C5 D15 C6 D1 C6 D15 EOT FU

Visit Schedule of Procedures

$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
$ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

Non-Procedures
Pharmacy $ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Coordinator (CRC/RN/Admin) $ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
PI $ - 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Subtotal 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
indirects 25% 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Total $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00 $0.00

Sponsor's per visit budget 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Difference 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

Non refundable start up fees (includes OH): Quantity Amount Total

Local IRB fee 1 $ - $ -
Regulatory prep & submission 1 $ - $ -
Pharmacy Fee 1 $ - $ -
Administrative Study Start up 1 $ - $ -
Principal Investigator start up fee 1 $ - $ -
Total start up $ -

Invoice items Quantity Amount Amount

Study close out fee 0 $ - $ -
Annual Pharmacy fee 0 $ - $ -
Annual Regulatory/maintenance fee 0 $ - $ -
Protocol amendment fee 0 $ - $ -
Monitor change fee (per permanent change) 0 $ - $ -
unscheduled visits ($ per hr) 0 $ - $ -
Conference calls ($ ea) 0 $ - $ -
SAE fee per each 0 $ - $ -
IND letters ($ ea) 0 $ - $ -
Total Invoice items $ -

Subject costs 0 $ - $ -

Total costs $ -

Sponsor Subject Reimb 0 $ - $ -

Sponsor Start up & Inv Reimb $ -
Difference $ -

*RC/S/V = Routine Care (RC), Research Care (S), Variable (V)

Sample Budget

Description RC/S/V Unit amt Screening C1 D1 C1 D15 C2 D1 C2 D15 C3 D1 C3 D15 C4 D1 C4 D15 C5 D1 C5 D15 C6 D1 C6 D15 EOT FU Total

Visit Schedule of Procedures

Informed consent $ 200.00 200.00 $ 200.00
Physical Examination, Height, Weight V $ 175.00 175.00 RC RC RC 175.00 $ 350.00
Blood draw RC $ - RC RC RC RC RC RC $ -
ECOG $ 50.00 50.00 50.00 50.00 50.00 50.00 $ 250.00
CMPL RC $ - RC RC RC RC RC RC $ -
Mag/Phosphorus S $ 40.00 40.00 $ 40.00
Urine pregnancy test S $ 30.00 30.00 $ 30.00
Urinalysis S $ 30.00 30.00 $ 30.00
CBC RC $ - RC RC RC $ -
Total Ige S $ 45.00 45.00 45.00 45.00 $ 135.00
PT/PTT S $ 60.00 60.00 $ 60.00
ECG S $ 150.00 150.00 150.00 150.00 150.00 $ 600.00
Echocardiogram S $ 1,000.00 1,000.00 1,000.00 $ 2,000.00
Chest X Ray V $ 175.00 175.00 RC RC 175.00 $ 350.00
Antibody testing RC $ - RC RC RC $ -
AE/ Con Meds $ 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 $ 400.00
Biomarkers $ 40.00 40.00 40.00 40.00 40.00 40.00 40.00 40.00 40.00 $ 320.00
Telephone contact $ 50.00 50.00 $ 50.00

Non-Procedures
Pharmacy $ 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 $ 750.00
Coordinator (CRC/RN/Admin) $ 75.00 225.00 75.00 75.00 75.00 75.00 75.00 75.00 75.00 75.00 75.00 75.00 75.00 75.00 75.00 75.00 $ 1,275.00
PI $ 120.00 360.00 120.00 120.00 120.00 120.00 120.00 120.00 120.00 120.00 120.00 120.00 120.00 120.00 120.00 120.00 $ 2,040.00
Subtotal 2,635.00 380.00 285.00 495.00 285.00 340.00 335.00 445.00 285.00 390.00 285.00 295.00 285.00 1,845.00 295.00 $ 8,880.00
indirects 25% 658.75 95.00 71.25 123.75 71.25 85.00 83.75 111.25 71.25 97.50 71.25 73.75 71.25 461.25 73.75 $ 2,220.00
Total $3,293.75 $475.00 $356.25 $618.75 $356.25 $425.00 $418.75 $556.25 $356.25 $487.50 $356.25 $368.75 $356.25 $2,306.25 $368.75 $ 11,100.00

Sponsor's per visit budget 2,000.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 2,000.00 1,200.00 $ 10,000.00
Difference 1,293.75 75.00 -43.75 218.75 -43.75 25.00 18.75 156.25 -43.75 87.50 -43.75 -31.25 -43.75 306.25 -831.25 $ 1,100.00

Non refundable start up fees (includes OH): Quantity Amount Total

Local IRB fee 1 $ 1,250.00 $ 1,250.00
Regulatory prep & submission 1 $ 5,000.00 $ 5,000.00
Pharmacy Fee 1 $ 1,500.00 $ 1,500.00
Administrative Study Start up 1 $ 5,000.00 $ 5,000.00
Principal Investigator start up fee 1 $ 2,250.00 $ 2,250.00
Total start up $ 15,000.00

Invoice items Quantity Amount Amount

Study close out fee 1 $ 3,000.00 $ 3,000.00
Annual Pharmacy fee 3 $ 500.00 $ 1,500.00
Annual Regulatory/maintenance fee 3 $ 500.00 $ 1,500.00
Protocol amendment fee 2 $ 800.00 $ 1,600.00
Monitor change fee (per permanent change) 2 $ 500.00 $ 1,000.00
unscheduled visits ($ per hr) 10 $ 75.00 $ 750.00
Conference calls ($ ea) 10 $ 50.00 $ 500.00
SAE fee per each 10 $ 600.00 $ 6,000.00
IND letters ($ ea) 50 $ 25.00 $ 1,250.00
Total Invoice items $ 17,100.00

Subject costs 10 $ 11,100.00 $ 111,000.00

Total costs $ 143,100.00

Sponsor Subject Reimb 10 $ 10,000.00 $ 100,000.00

Sponsor Start up & Inv Reimb $ 15,000.00
Difference $ 28,100.00
INDUSTRY SPONSORED BUDGET WORKSHEET

Principal Investigator:
Study Title:
Sponsor:

Description Amount

Personnel (includes ERE) $ -

IRB $ -
Other $ -
Subtotal $ -

Indirects $ -

Total $ -

This document is meant to aide in the process of conducting a clinical trial and its usage is not required.