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Determining % Effort for Clinical Trial Kathy Price, RN, MBA Manager, GI Clinical Research
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Approaches Historical data to determine nursing time Determine % effort proposed by sponsor Compare sponsor’s % effort to historical data (your estimate of % effort required) Know your bottom $ before submitting budget to sponsor
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Historical Data Do time studies over several months. Record time spent on activities per study, for example: Recruitment Screening Consenting Patient Visit Blood specimens (collection, processing, shipping) CRF Completion Query Resolution Outside Safety Reports
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Calculate % effort offered by sponsor. Sponsor offers $6,334 per patient 1st Subtract 29% indirect rate; $6,334 - 1,837 = $4,497 2nd Determine Actual per Patient Costs: Venipuncture: $10 X 8 visits = $80 Drug Dispense: $15 X 2 = 30 Pt. Reimbursement: $50 X 8 visits = $400 PI % effort: (annual salary + fringes) X.01 = 1% effort ÷ # pts = $854 per patient Pt. Cost = $1,364 w/o nurse salary
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Subtract costs from per patient reimbursement minus indirect costs $4,497 Sponsor per pt reimbursement - 1,364 Costs, not including nursing $3,133 per pt available for nursing effort
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Determine nursing hourly rate Typical market average ~ $45 per hour. Research Nurse Specialist II Salary = $62,130 Add fringe rate at 25.6% = $78,035 annual salary Divide by 2088 hours (annual work hours) = $37.37 per hour nursing cost
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$3,133 per pt available for nursing costs Divide by $40 per hour = 78 hours per patient or 9.8 hours per visit/per pt 3,133 X 5 pts = $15,665 nursing effort $15,665 ÷ $78,035 = 21% nursing effort offered for the conduct of this study.
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Determine Your Estimate of per Patient Nursing Hours Using Study Calendar, assign hours to complete activity. For each visit, be sure to consider the following: Recruitment Activity (clinic visit schedules) Actual Patient Visit Time Medical Record Entry/Source Document CRF Completion Query Resolution Procedural Costs( i.e., ECG, CXR, etc.) Procedure set-up Blood Processing and shipping Adverse Events
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Study Calendar VisitScreen123 Consent$80 Medical History$40 Randomization$40 Physical Exam$40 Review Inc/Exc$40 Labs, processing, shipp$40 Hematology (local)$30 Total$270$120
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Additional Fees Not included in per pt. costs Up-Front Non-Refundable Costs –Regulatory Management Fee $2,500.00 –IRB Submission Packet Preparation $1,600.00 –Budget Prep, Invoicing, Billing $250.00 –Contract Submission Preparation $250.00 –PI and Coordinator Time for Study Evaluation $1,000.00 –Pharmacy budget estimate $100.00 –Start-up meetings, Initiation visit, Investigator meeting attendance $800.00 –Staff Training $500.00 –Archival fee $500.00 Institution shall invoice for the following costs, as they occur not to exceed the amounts listed below: –Pharmacy Fees: $2,500.00 –IRB Initial Review: $3,000 –IRB Continuing Review: $1,500 –IRB Amendments $1,000
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Account Reconciliation
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Edog access PAGE 1
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PAGE 2
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Monthly ledger PAGE 3
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1. Click on appropriate center account 2. 4. 3. Choose fiscal year Choose month Select “all reports” PAGE 4
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Beginning balance Ending balanceAugust total expense Accounting methods Pt. reimbursements via check requests total check requests Outpatient expenses Beginning balance again Indirect charges
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