Clinical Trial Budgets K.J. Sprenger, RN BS, Clinical Research Manager University of Iowa Roy J. and Lucille A. Carver College of Medicine, Iowa City, Iowa, United States.

What is a Budget Best estimate of the financial resources needed to accomplish the research study. Outlines the Direct Costs and Indirect Costs. Costs may be one time or recurring throughout the study. Must capture all possible charges.

Budget Development 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.

Budget Development 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, Core Lab or an ancillary lab like the Cell Lab.

Budget Development 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.

Budget Development 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.

Budget Development 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%20Documents/Res%20Billing_Sept%202014%20pr esentation.pptx

Sponsor Budget screening Day 0 Day 1 Day 2 Day 3 Day 7 Day 28 Day 90   screening Day 0 Day 1 Day 2 Day 3 Day 7 Day 28 Day 90 Day 365 Informed Consent $ 150 Inclusion/Exclusion $ 100 $ 100 Physical Exam SOC $ 150 includes height and weight at screening medical history Chemistry Hematology Respiratory Function $ 200 $ 200 only required if on ventilator. Includes rate, tidal volume, and airway pressures, PaO2 /FiO2 and PEEP Pregnancy test $ 30 ECG Vital Signs Investigational Product preparation and infusion $ 700 Blood sample for exploratory biomarkers $ 50 Hospitalization data EQ-5D $ 25 Adverse Events Concomitant Medications PI $ 300 $ 300 SC $ 250 $ 250 Total $ 1,330 $ 2,150 $ 750 $ 900 $ 925 $ 575 overhead 25% $ 333 $ 538 $ 188 $ 225 $ 231 $ 144 visit total $ 1,663 $ 2,688 $ 938 $ 1,125 $ 1,156 $ 719 total per subject $11,069

  screening Day 0 Day 1 Day 2 Day 3 Day 7 Day 28 Day 90 Day 365 Informed Consent $ 300 Inclusion/Exclusion $ 100 $ 100 Physical Exam SOC $ 150 medical history Chemistry Hematology Respiratory Function $ 200 $ 200 Pregnancy test $ 30 ECG Vital Signs Investigational Product preparation and infusion $ 1,500 Blood sample for exploratory biomarkers $ 87 Hospitalization data $ 50 EQ-5D Adverse Events Concomitant Medications Subject $ 55 PI $ 300 SC Total $ 1,530 $ 3,037 $ 787 $ 937 $ 1,005 $ 655 26% $ 398 $ 790 $ 205 $ 244 $ 261 $ 170 visit total $ 1,928 $ 3,827 $ 992 $ 1,181 $ 1,266 $ 825 total per subject $13,016

One Time Costs or Invoice Items 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 1st 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

One Time Costs or Invoice Items 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

Example of One Time Or Invoice Items In A Budget 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 refresher training - per processor and verifier 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 Annual Regulatory and Financial Maintenance Fee--After 1st 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

I-CART 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://icts.uiowa.edu

Sponsor Budget

Click: Submit to Start Services

How to find pricing list

Documentation of Research Participation We must document a subjects participation in a research study based on the following policy: IM-MR-06.21: DOCUMENTATION OF PATIENT PARTICIPATION AS A SUBJECT IN A RESEARCH PROTOCOL OR USE OF AN INVESTIGATIONAL MEDICATION, STUDY MEDICATION, INVESTIGATIONAL DEVICE, OR BIOLOGIC This is an updated policy, all research team members will be required to take the Policy Awareness training in ICON.

Documentation of Research Participation At least one team member will be required to be trained on how to request a study to be built in EPIC. At least one team member will be required to be trained on how to associate a subject to a study and maintain the subject’s status in EPIC.

PUrpose To provide a mechanism to identify for healthcare providers that a patient is a participant in a research protocol or using an investigational medication, study medication, investigational device, or biologic and to provide a means to ensure that health care providers have appropriate clinical information related to the study in the event that participation may have clinical significance to the patient’s care. To provide guidelines for documenting research subjects who are not patients that are participating in protocols within UI Health Care facilities.

Three Study categories 1. Requires EPIC Build and Entry: Procedures, tests, examinations, hospitalizations, use of Pathology services, use of clinic facilities or clinical equipment, or any patient care services, including services conducted in the Clinical Research Unit. 2. Enter into Low Risk Database A study that has physical interactions with a subject that do not fit into the criteria for Requires Epic Description or Exempt categories. An example would be at study involves a PFT test and 6 minute walk test performed in the Field House.

Three Study categories 3. Exempt: Observational studies that don’t require physical interaction with the subject. An example would be a retrospective data chart extraction.

Once you determine study Type If meets criteria for entry into EPIC, request an EPIC build using ICart: https://www.icts.uiowa.edu/ If meets criteria for entry in low risk data base enter using the following link: https://redcap.icts.uiowa.edu/redcap/surv eys/?s=yjnt3X If exempt no action needed.

Remember All team members must take the Policy Awareness training. One team member must be trained on how to request an EPIC build and associate subjects. All subjects need to be entered the day of their visit. All subjects need to have their status updated in a timely manner.

Remember for your Budget 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% Good Clinical Practice in a budget means maintaining a fair market price. Make sure all costs are covered but not unrealistically inflated.

Questions? Contact me at kimberly-sprenger@uiowa.edu 319-353-8862 Always better to ask than to regret it!