Determining % Effort for Clinical Trial Kathy Price, RN, MBA Manager, GI Clinical Research

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

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

Calculate % effort offered by sponsor. Sponsor offers $6,334 per patient 1st Subtract 29% indirect rate; $6, ,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

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

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

$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.

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

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

Additional Fees Not included in per pt. costs Up-Front Non-Refundable Costs –Regulatory Management Fee $2, –IRB Submission Packet Preparation $1, –Budget Prep, Invoicing, Billing $ –Contract Submission Preparation $ –PI and Coordinator Time for Study Evaluation $1, –Pharmacy budget estimate $ –Start-up meetings, Initiation visit, Investigator meeting attendance $ –Staff Training $ –Archival fee $ Institution shall invoice for the following costs, as they occur not to exceed the amounts listed below: –Pharmacy Fees: $2, –IRB Initial Review: $3,000 –IRB Continuing Review: $1,500 –IRB Amendments $1,000

Account Reconciliation

Edog access PAGE 1

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Monthly ledger PAGE 3

1. Click on appropriate center account Choose fiscal year Choose month Select “all reports” PAGE 4

Beginning balance Ending balanceAugust total expense Accounting methods Pt. reimbursements via check requests total check requests Outpatient expenses Beginning balance again Indirect charges