BUDGET FOR UCI CLINICAL TRIAL
Published on April 15, 2015
Exhibit 10.3
Protocol No.: UCI 14-25 Plasma Exosome Concentration in Cancer Patients Undergoing Treatment
Protocol Target Accrual: 45 PI: Edward Nelson, MD
Short Title: Plasma Exosome Concentration in Cancer Patients Undergoing Treatment
Startup Charges
| Event | Negotiated Charge |
| Protocol Set-Up & Administration Fees (Feasibility, Budget, Medicare Cost Coverage, IRB Application/Doc Prep, IRB Institutional Review Fee, Annual CRC Administrative Fees, and Study Supplies) |
15,105.00 |
| Subtotal: | 15,105.00 | |||
| Overhead Charges @ 0.0%: | 0.00 | |||
| Indirect Costs @ 26.0%: | 3,927.30 | |||
| Total Startup Charges: | 19,032.30 |
Per Subject Visit Charges (Items include 26.0% indirect charges)
| # occurances | Event | # of Subjects | Visit Reimbursement |
| 1 | Phlebotomy | 45 | 84.00 |
| 1 | Cancer Center Data Management | 45 | 1,497.00 |
| 1 | Study Oversight, Coordination, and Biostatistics | 45 | 1,778.00 |
| Total Subject Charges (Maximum) | 3,359.00 |
| Direct Cost Subtotal for (1) Subjects: | 2,665.87 | |||
| Indirect Costs @ 26.0%: | 693.13 | |||
| Total Per Subject Charges for (1) Subjects | 3,359.00 | |||
| Total Per Subject Charges for (45) Subjects | 151,155.00 |
Protocol Related Variable Passthrough Charges (Items include 26.0% indirect charges)
| Event | Negotiated Charge | |||
| Protocol Annual Renewal Prep Fee (Payment triggered at IRB renewal. Includes study project management outside visit activities for sponsor site visits, IRB renewal prep, bill reconciliation, OnCore managment, SAE reporting, IRB modifications, close out and storage, etc.) | 7,000.00 | |||
| IRB Committee Renewal Review Fee | 1,039.50 | |||
| Consent Translation (Pass through cost, based on language and length of document) | TBD | |||
| Other Tests/Procedures not included above | TBD |