VanessaLBlauBUDGETINGFORINDUSTRYSPONSORED学习课件.pptVIP

Weill Medical College of Cornell University Budgeting for Clinical Trials Updated September 11, 2006 BUDGETING FOR INDUSTRY SPONSORED CLINICAL TRIALS Industry Sponsored Clinical Trial Budgets Steps: Pre-budget Preparation HRBAF Preparation Initial Budget Drafting Feasibility Meetings Further Develop the Study Budget Draft Final HRBAF Verification Account Set-up Initial Invoicing Budgeting Steps for Clinical Trials Step 1 Pre-Budget Preparation Understand the Study Do a 3 Point Comparison Compare contrast to ensure all procedures/events are included in these 3 documents: Informed Consent Form (ICF) Schedule of Events (within Protocol) Sponsor’s Budget Line Items Step 2 HRBAF Preparation List protocol activities on the HRBAF Human Research Billing Analysis Form Formerly CTAF or Billing Compliance Form Determine whether procedures are Standard of Care or Research Specific Obtain CPT ICD9 codes Refer to your Department Billing Compliance Liaison /billingcompliance/pdf/2_2_dep_com_sta.pdf Refer to instructions for HRBAF /billingcompliance/pdf/InstructionsIV.pdf Step 3 Initial Budget Drafting Tips: Obtain costs for conducting trial activity Use codes from HRBAF ICR Templates available Consider factors that impact the study budget: Sponsor Initiated v. Investigator Initiated Device v. Drug Phase I, II, III, IV Ancillary Research Services Administrative Tasks Building the Budget Review Consider Payment Schedule—based on CRF completion, milestones Study Duration—include inflation factor Invoiceable Fees Ex: Advertising, Patient Travel Reimbursement, Screen Failures, Regulatory Continuing review fees, Postage, Amendments, Monitoring Visits Mandatory Fees Mandatory Fees Get estimate from Research Pharmacy Contact them at 746-0743 Non-refundable Initial Payment including: IRB Fee: $1,500 (set by RASP) Start up costs (determined by department) IDC: 33% (set by WCMC Board of Trustees) Per Patient Budget Activity Based Procedures Calculate t