Separation of Allowable Costs Study Title: Study Sponsor: Protocol Number: Principle Investigator: Study Coordinator: Sponsor Contact: Location of Study: Planned Enrollment: Clinical Trial Billing Grid Procedures Informed Consent Concomitant Medications Medical History Physical Exam Vital Signs ECG Serum Preg. Test (HCG) Complete CBC / Auto Creatinine AST/ALT Alkaline Phosphatase LDH Sodium Magnesium PK Chest CT Dose Administration SAE Reporting CRF Completion Other Misc. Admin Randomized Phase II Study to Evaluate STUDY DRUG Treatment versus Placebo in Patient Population SPONSOR, INC IURX1234 John Doe, MD June Smith Joe Smith COMPANY ABC (123) 456-7890; joe.smith@abc.com University Hospital 5 Baseline SPONSOR SPONSOR SPONSOR RC RC SPONSOR SPONSOR RC RC RC RC SPONSOR RC SPONSOR SPONSOR RC SPONSOR SPONSOR Week 1 Treatment Week 2 Week 3 Week 4 Follow Up Month 2 Month 4 SPONSOR SPONSOR RC RC RC RC RC RC SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR RC RC RC RC SPONSOR RC SPONSOR SPONSOR RC RC RC RC RC SPONSOR RC SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR RC (Routine Care) - Billed to Patient's Insurance; SPONSOR-Billed to Sponsor Office of Research Administration (03.2010) SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR SPONSOR 1 2 Separation of Allowable Costs 3 DETERMINATION OF RESEARCH SERVICES 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 Please Check Appropriate Reimbursement Source Principal Investigator: Study Title: Sponsor: Research (Required by study and paid by sponsor) Routine Care (Standard of Care- to be paid by insurer/patient) A. STARTUP COSTS (non-refundable): Investigator Meeting Coordinator Meeting IRB Fee: Protocol & Consent Form Review, Submission & Closure: Administrative Fee: Storage: Pharmacy Set Up & Storage: Other: B. OTHER COSTS: Travel Site Training Advertising Equipment Dry Ice Space rent Other C. PER PATIENT COSTS: Screening Assessment : EFFORT-BASED COSTS Informed Consent Inclusion/Exclusion Criteria Chart Review Medical History Randomized Phase II Study to Evaluate STUDY DRUG Treatment Vitals & Blood Pressure versus Placebo in Patient Population Study Title: Physical Examination Review Adverse Reactions Office of Research Administration (03.2010) Medication Dispensing/Returning EXPENSE-BASED COSTS Clinic Visit X rays & Scans Separation of Allowable Costs Study Sponsor: Protocol Number: Principle Investigator: Study Coordiantor: Sponsor Contact: Location of Study: Planned Enrollment: SPONSOR, INC IURX1234 John Doe, MD June Smith J. Smith COMPANY ABC (123) 456-7890; joe.smith@abc.com University Hosp. 5 Clinical Trial Billing Grid Procedures Informed Consent Concominant Medications Medical History Baseline Physical Exam Vital Signs ECG Serum Preg. Test (HCG) Complete CBC / Auto Creatinine AST/ALT Alkaline Phosphatase LDH Sodium Magnesium PK Chest CT Dose Administration SAE Reporting CRF Completion Other Misc. Admin $100.00 $50.00 $135.00 $35.00 $100.00 $25.00 $40.00 $30.00 $10.00 $10.00 $10.00 $40.00 $1200.00 Routine Care-billed to Ins. Week 1 Treatment Week 2 Week 3 Week 4 Follow Up Month 2 Month 4 $50.00 $50.00 $100.00 $50.00 $100.00 $50.00 $100.00 $50.00 $25.00 $25.00 $40.00 $30.00 $10.00 $10.00 $10.00 $40.00 $100.00 $25.00 $40.00 $30.00 $10.00 $10.00 $10.00 $40.00 $1200.00 100.00 $25.00 $40.00 $30.00 $10.00 $10.00 $10.00 $40.00 $50.00 $35.00 $50.00 $35.00 $150.00 $50.00 $200.00 $50.00 $35.00 $20.00 $50.00 $35.00 $3000.00 Sponsor-Billed to sponsor Office of Research Administration (03.2010) $20.00 $50.00 $35.00 $50.00 $20.00 $50.00 $35.00 $20.00 $50.00 $35.00