K J Sprenger RN BS University of Iowa
K. J. Sprenger, RN BS, University of Iowa Roy J. and Lucille A. Carver College of Medicine, Iowa City, Iowa, United States.
The sponsor of the clinical trial will send a contract and budget for the trial. Think about the following: Can we recruit subjects? How many can we recruit realistically? Does the budget support the work to be done on the trial? What type of staff is needed? After reviewing the budget, protocol and the questions start modifying the budget to reflect your costs to conduct the trial.
Find the study overview in the protocol. This is often a one page visit-by-visit outline of the study. Determine if the labs and testing procedures such as EKG’s, MRI scans, etc. will be analyzed at our local University of Iowa core lab or at the sponsor’s central site. Will there be other department charges: CRU, Nursing, Cell Lab
Determine if there will be professional charges required for the technical tests performed. An example would be an ECG with interpretation by a Cardiologist. You want to negotiate a cost per subject to complete a clinical trial, not a cost per test or procedure. You may use a standard of care test result for clinical research if the protocol allows.
Remember you may not bill insurance for a test, device, or service paid for by the Sponsor. If you anticipate your trial last multiple years, consider adding on a 7% inflation rate to each cost. All expenses are subject to F&A (Facilities and Administrative Costs) or Indirect Costs (Overhead) of 26% for industry sponsored studies.
The following site has pricing and coding tools that can assist you in budget development: https: //thepoint. healthcare. uiowa. edu/sites/Compliance/resear chbilling Excellent Presentation on why the JOC was developed: https: //thepoint. healthcare. uiowa. edu/sites/Compliance/resear chbilling/Shared%20 Documents/Res%20 Billing_Sept%202014%20 pr esentation. pptx
screening Informed Consent Inclusion/Exclusion Physical Exam medical history Chemistry Hematology Respiratory Function Pregnancy test ECG Vital Signs Day 0 $ 150 $ 100 SOC $ Day 1 $ 100 $ 150 Day 2 Day 3 $ Day 7 150 $ Day 28 150 Day 90 $ 150 Day 365 $ 150 $ 200 $ 50 $ 25 100 SOC SOC SOC $ 200 $ $ $ 200 SOC $ 700 $ 50 $ 200 $ 30 200 200 only required if on ventilator. Includes rate, tidal volume, and airway pressures, Pa. O 2 /Fi. O 2 and PEEP SOC SOC SOC Investigational Product preparation and infusion Blood sample for exploratory biomarkers $ 50 Hospitalization data EQ-5 D Adverse Events $ 100 $ 100 $ 100 $ 100 $ 100 PI $ 300 $ 100 $ 100 SC $ 250 $ 200 $ 200 $ 100 $ 1, 330 $ 2, 150 $ 750 $ 900 $ 925 $ 575 $ 333 $ 538 $ 188 $ 225 $ 231 $ 144 $ 1, 663 $ 2, 688 $ 938 $ 1, 125 $ 1, 156 $ 719 Concomitant Medications Total overhead 25% visit total per subject includes height and weight at screening $11, 069 $ 1, 125
screening Day 0 Day 1 Day 2 Day 3 Day 7 Informed Consent $ 300 Inclusion/Exclusion $ 100 Physical Exam SOC $ 150 medical history $ Chemistry SOC SOC SOC Hematology SOC SOC SOC Respiratory Function $ 200 $ Pregnancy test $ 30 ECG SOC Vital Signs SOC $ 150 $ Day 28 150 $ Day 90 150 $ Day 365 150 $ 150 100 $ 200 SOC Investigational Product preparation and infusion $ 1, 500 Blood sample for exploratory biomarkers $ 87 $ 200 $ SOC 87 $ 200 SOC 87 $ 87 Hospitalization data $ 50 EQ-5 D $ 50 Adverse Events $ 100 $ 100 $ 100 Concomitant Medications $ 100 $ 100 $ 100 $ 55 Subject PI $ 300 $ 100 $ 100 SC Total $ 300 $ 200 $ 200 $ 100 1, 530 $ 3, 037 $ 787 $ 937 $ 1, 005 $ 655 26% $ 790 $ 205 $ 244 $ 261 $ 170 visit total $ 1, 928 $ 3, 827 $ 992 $ 1, 181 $ 1, 266 $ 825 total per subject $ 398 $ $13, 016
Start up fees $ 17, 010 WIRB fees upon invoice Initial Training-IP Prep + Docs- Per Processor $54. 00 Aseptic Processing, Cell CT + Docs- Per Verifier $54. 00 Refresher training - per processor and verifier $54. 00 CRU room fee for outpatient visits $80. 00 UI Human Subjects Office (HSO) Fee $1, 500. 00 CRU Review Fee $573. 00 CRU Order Building $110. 00/hr Training $110. 00/hr Annual Regulatory and Financial Maintenance Fee--After 1 st Year $2, 000. 00 UI Human Subjects Office (HSO) continuing review Fee $750. 00 Binder fee $400. 00 Monitoring Visits, Per Day $400. 00/day Study Closeout $1, 000. 00 Long Term storage fee $500/yr Audit fee $1000. 00/day
Investigational Drug Pharmacy set-up fee Investigational Drug Pharmacy annual fee Advertising for Recruitment Fee (estimated based on study) Refer to Start Up Fee, Invoice and Financial Expectations sheet for additional items Be sure to add on the Indirect Cost of 26% on one time costs
• Iowa Catalogue and Research Tracker • I-CART is a web-based tool that allows researcher and teams to: – Budget, – Select and – Order research services. • All in one place! • https: //www. icts. uiowa. edu/
Click: Submit to Start Services
• Include all costs • The budget must total the estimated patient costs plus all one-time fees. • All industry sponsored expenses are subject to F&A which is 26%
• Contact me at kimberly-sprenger@uiowa. edu • 319 -353 -8862 • Always better to ask than to regret it!
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