K J Sprenger RN BS Clinical Research Manager

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.

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, Core Lab or an ancillary lab like the 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 Day 0 $ $ Day 2 Day 3 Day 7 Day 28 Day 90 Day 365 100 Inclusion/Exclusion 150 Day 1 Physical Exam $ $ 150 SOC 100 medical history $ Chemistry 100 $ 150 $ 150 SOC SOC SOC $ $ $ Hematology Respiratory Function $ 200 $ 30 Pregnancy test ECG 200 200 200 $ 200 only required if on ventilator. Includes rate, tidal volume, and airway pressures, Pa. O 2 /Fi. O 2 and PEEP SOC Vital Signs SOC $ 200 $ 700 $ SOC 50 SOC SOC Investigational Product preparation and infusion Blood sample for exploratory biomarkers Hospitalization data EQ-5 D Adverse Events $ 50 $ 50 $ 25 $ 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

Informed Consent screening Day 0 Day 1 Day 2 Day 3 Day 7 Day 28 Day 90 Day 365 $ 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 100 $ 200 $ $ 150 $ 200 SOC 150 $ 200 $ SOC 150 $ SOC 200 87 150 200 $ SOC Investigational Product preparation and infusion $ 1, 500 Blood sample for exploratory biomarkers $ Hospitalization data $ 50 EQ-5 D $ 50 87 $ 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

start up fees $ WIRB fees Initial Training-IP Prep + Docs- Per Processor Asceptic Processing, Cell CT + Docs- Per Verifier referesher training - per processor and verifier CRU room fee for outpatient visits UI Human Subjects Office (HSO) Fee CRU Review Fee CRU Order Building Training Annual Regulatory and Financial Maintenance Fee--After 1 st Year UI Human Subjects Office (HSO) continuing review Fee Binder fee Monitoring Visits, Per Day Study Closeout Long Term storage fee Audit fee 17, 010 upon invoice 54. 00 80. 00 1, 500. 00 573. 00 $110. 00/hr 2, 000. 00 750. 00 400. 00 $400. 00/day 1, 000. 00 $500/yr $1000. 00/day

• 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

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.

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.

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.

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.

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

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=yjnt 3 X If exempt no action needed.

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.

• 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.

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