Study Budgets: Industry Sponsored Studies Kelsey Richey Center for - - PowerPoint PPT Presentation

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Study Budgets: Industry Sponsored Studies Kelsey Richey Center for - - PowerPoint PPT Presentation

Oct 24, 2022 171 likes •583 views

Study Budgets: Industry Sponsored Studies Kelsey Richey Center for Clinical Research (CCR) Learning Objectives Identify the components of a clinical trial budget Identify hidden costs Topic Overview Budget Development Basics

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SLIDE 1

Study Budgets: Industry Sponsored Studies

Kelsey Richey Center for Clinical Research (CCR)

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SLIDE 2

Learning Objectives

  • Identify the components of a clinical trial budget
  • Identify hidden costs
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SLIDE 3

Topic Overview

  • Budget Development Basics
  • Components of a Clinical Trial Budget
  • Subject Costs
  • Non-Subject Fees/ Admin. Fees/ Contingent Fees
  • Useful Tips
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SLIDE 4

Budget Development Basics

  • What you need:
  • The sponsors budget template
  • Contract
  • Protocol
  • Schedule of Assessments
  • Informed Consent
  • May need:
  • Imaging Manual
  • Laboratory Manual
  • Pharmacy Manual

Documents Needed

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SLIDE 5

Budget Development Basics Example Internal Budget (see sample legal size template)

Center for Clinical Research (CCR) Financial Services Program Investigator: Protocol #: Sponsor: NUCATS Study #: SP0#: Chart string: Event Screening Baseline D1 D7 D14 M24 M27 EOS EOT Visit 1 2 3 4 5 14 15 16 Total Per Subject Total for 1 Subjects Coordinator: Pat Casey, 1% Effort Informed consent X Elizabeth Kidd, 5% Effort Demography, Height X Medical history X MS History/Treatments X Incl/Excl X X Phone interview X X X X X X X Patient diary review X X X Contraception status X X X X X Vital signs, Weight X X X X X X X X Prior/Con Meds X X X X X X X X eCSSRS X X X X X X X X T25FW X X X X X 9HPT X X X X SDMT X X X X MSIS-29 X X X X EQ-5D X X X X WPAI:MS X X X X PRO Completion form X X X X Visit Length (hours) 10.0 10.0 5.0 5.0 5.0 10.0 5.0 10.0 3.0 Per Patient Effort (includes benefits) 0.0 # Of Years Effort will be Applied 0.0 % Future Year Increases 0% Total Coordinator: 654.14 $ 654.14 $ 327.07 $ 327.07 $ 327.07 $ 654.14 $ 327.07 $ 654.14 $ 7,522.62 $ 7,522.62 $ Physician: Bruce Cohen, 2% Effort Physical Exam X X X X X Per Patient Effort (includes benefits) # Of Years Effort will be Applied 0.0 % Future Year Increases 0% Total Physician: 1,224.13 $ 1,224.13 $ 612.07 $ 612.07 $ 612.07 $ 1,224.13 $ 612.07 $ 1,224.13 $ 14,077.54 $ 14,077.54 $
  • $
Labs: Central labs (processed by Coord) X X X X X Pregnancy Test 25 25 25 25 25 Subtotal 25.0 0.0 25.0 0.0 0.0 25.0 25.0 25.0 0.0 # Of Years Study will Utilize Lab Services 0.0 % Future Year Increases 0% Total Labs: 25.00 $
  • $
25.00 $
  • $
  • $
25.00 $ 25.00 $ 25.00 $ 325.00 $ 325.00 $
  • $
NMHC: Radiology ECG X 100 100 100 MRI 2750 2750 2750 2750 Subtotal 2750.0 100.0 0.0 0.0 0.0 2750.0 0.0 2850.0 2850.0 # Of Years Study will Utilize NMHC 0.0 % Future Year Increases 0% Total NMHC: 2,960.91 $ 107.67 $
  • $
  • $
  • $
2,960.91 $
  • $
3,068.58 $ 12,058.99 $ 12,058.99 $ 2,850.00 $ Misc: EDSS 155 X 155 155 155 25 Subtotal 155.0 0.0 0.0 0.0 0.0 155.0 155.0 155.0 25.0 # Of Years Study will Utilize NMG 0.0 % Future Year Increases 0% Total NMG: 166.89 $
  • $
  • $
  • $
  • $
166.89 $ 166.89 $ 166.89 $ 1,835.77 $ 1,835.77 $ 50.00 $ Travel/Stipend/Administration: Form of payment 25 25 25 25 25 25 25 25 Travel/Stipend/Administration: 25.00 $ 25.00 $ 25.00 $ 25.00 $ 25.00 $ 25.00 $ 25.00 $ 25.00 $ 400.00 $ 400.00 $
  • $
Pharmacy: CPT code 150 150 150 150 150 Total Pharmacy:
  • $
  • $
150.00 $ 150.00 $ 150.00 $ 150.00 $ 150.00 $
  • $
1,950.00 $ 1,950.00 $
  • $
Subtotal Per Patient/Per Visit 5,056.08 $ 2,010.95 $ 1,139.14 $ 1,114.14 $ 1,114.14 $ 5,206.08 $ 1,306.03 $ 5,163.75 $ 38,169.93 $ 38,169.93 $ 2,900.00 $ 30% Indirect Cost Rate 1,516.82 $ 603.28 $ 341.74 $ 334.24 $ 334.24 $ 1,561.82 $ 391.81 $ 1,549.12 $ 11,450.98 $ 11,450.98 $ 870.00 $ Total per patient per visit 6,572.90 $ 2,614.23 $ 1,480.88 $ 1,448.38 $ 1,448.38 $ 6,767.90 $ 1,697.83 $ 6,712.87 $ 49,620.91 $ 49,620.91 $ 3,770.00 $ Estimated Number of Subjects: 1 Total Subject Budget (if all 1 subjects are enrolled and remain in the study for the life of the study): 49,620.91 $ Sponsors Budget Offer/Amount in Contract 5,777.10 $ 1,362.60 $ 1,377.00 $ 1,425.60 $ 1,425.60 $ 5,801.40 $ 1,659.60 $ 5,728.50 $ 42,375.60 $ 2.5 3% 2.5 3% 2.5 3% Draft Budget 7-Jul-2016 $3,888.29 2.5 3% $7,276.39

Coordinator Time/Effort PI (& Sub-I) Time/Effort NMG (Professional Fees) Subject Stipend Pharmacy Overhead NMHC (Hospital Fees) Labs

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SLIDE 6

Budget Development Basics Example Sponsor Budget (Every Sponsor will have a different template)

Coordinator Time/Effort PI (& Sub-I) Time/Effort NMG (Professional Fees) Subject Stipend Pharmacy Overhead NMHC (Hospital Fees) Labs

1.00 150.00 150.00 150.00 1.00 215.00 215.00 215.00 1.00 180.00 180.00 180.00 13.00 25.00 25.00 25.00 25.00 25.00 25.00 25.00 25.00 25.00 25.00 25.00 25.00 25.00 25.00 325.00 3.00 125.00 125.00 125.00 125.00 375.00 16.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 560.00 13.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 5,200.00 16.00 90.00 90.00 90.00 90.00 90.00 90.00 90.00 90.00 90.00 90.00 90.00 90.00 90.00 90.00 90.00 90.00 90.00 1,440.00 4.00 300.00 300.00 300.00 300.00 300.00 1,200.00 4.00 115.00 115.00 115.00 115.00 115.00 460.00 16.00 110.00 110.00 110.00 110.00 110.00 110.00 110.00 110.00 110.00 110.00 110.00 110.00 110.00 110.00 110.00 110.00 110.00 1,760.00 28.00 88.00 88.00 176.00 176.00 176.00 176.00 176.00 176.00 176.00 176.00 176.00 176.00 176.00 176.00 176.00 88.00 2,464.00 28.00 90.00 90.00 180.00 180.00 180.00 180.00 180.00 180.00 180.00 180.00 180.00 180.00 180.00 180.00 180.00 90.00 2,520.00 15.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 1,500.00 12.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 240.00 5.00 30.00 30.00 30.00 30.00 30.00 30.00 150.00 16.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 800.00 1,518.00 1,186.00 285.00 1,186.00 1,186.00 1,756.00 1,186.00 1,186.00 1,216.00 1,601.00 1,186.00 1,216.00 1,166.00 1,166.00 1,166.00 1,333.00 19,539.00 30.00% 455.40 355.80 85.50 355.80 355.80 526.80 355.80 355.80 364.80 480.30 355.80 364.80 349.80 349.80 349.80 399.90 5,861.70 1,973.40 1,541.80 370.50 1,541.80 1,541.80 2,282.80 1,541.80 1,541.80 1,580.80 2,081.30 1,541.80 1,580.80 1,515.80 1,515.80 1,515.80 1,732.90 25,400.70 16.00 130.00 130.00 130.00 130.00 130.00 130.00 130.00 130.00 130.00 130.00 130.00 130.00 130.00 130.00 130.00 130.00 130.00 2,080.00 16.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 2,640.00 13.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 260.00 16.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 50.00 800.00 345.00 365.00 345.00 365.00 365.00 365.00 365.00 365.00 365.00 365.00 365.00 365.00 365.00 365.00 365.00 345.00 5,780.00 30.00% 103.50 109.50 103.50 109.50 109.50 109.50 109.50 109.50 109.50 109.50 109.50 109.50 109.50 109.50 109.50 103.50 1,734.00 448.50 474.50 448.50 474.50 474.50 474.50 474.50 474.50 474.50 474.50 474.50 474.50 474.50 474.50 474.50 448.50 7,514.00 2,421.90 2,016.30 819.00 2,016.30 2,016.30 2,757.30 2,016.30 2,016.30 2,055.30 2,555.80 2,016.30 2,055.30 1,990.30 1,990.30 1,990.30 2,181.40 32,914.70 1.00 650.00 650.00 1.00 1,000.00 1,000.00 1.00 5,000.00 5,000.00 Each Year 750.00 1.00 750.00 750.00 1.00 5,000.00 5,000.00 1.00 3,900.00 3,900.00 Each Year 910.00 Each Year 75.00 Each 2,421.90 2.00 39.00 78.00 13.00 20.00 260.00 Annual Pharmacy Fee SAE report prep fee Screen Failure Site Start-up Costs Initial Pharmacy Fee Visit 9 - Week 24 Other Direct Costs Total Quan Selected Cost Visit 1 - Screening Visit 2 - Day 1 Visit 3 - Week 1 Per Patient Other Direct Cost: Overhead at Pharmacy Dispensing IRB Amendment Closeout Fee Visit 16 - Week 52 (End Total Physician's Fees without Exam Costs Salaries: Coord, Nurse, Admin, Tech Patient Daily Reimbursement Visit 10 - Week 28 Visit 11 - Week 32 Visit 12 - Week 36 Visit 13 - Week 40 Visit 14 - Week 44 Visit 15 - Week 48 Visit 4 - Week 4 Visit 5 - Week 8 Visit 6 - Week 12 Visit 7 - Week 16 Visit 8 - Week 20 Serum Pregnancy Test, Quantitative Urine Pregnancy Test, Qualitative Adverse Events Assessment Per Patient Procedure: Overhead at Per Patient Procedure Subtotal: Cost Per Patient Totals:

Invoice Items

Name Total Quan Selected Cost Total Per Patient Other Direct Cost Totals: Archiving/Document storage/per site Initial IRB Fee IRB Renewal Urinalysis ECG Review Concomitant Medications Intravitreal Injection of REGN2176-3 Or BCVA Fluorescein Angiography Fundus Photography SD-OCT Ocular Blood Flow by Repetitive IOP Indirect Ophthalmoscopy Slit Lamp Venipuncture/Sample Handling Visit 16 - Week 52 (End

  • f Study)

Total Informed Consent Complete Physical (Med Hx, Height,

  • Comp. Follow-Up Visit w Phys/Vitals

Visit 14 - Week 44 Visit 15 - Week 48 Vital Signs Visit 10 - Week 28 Visit 11 - Week 32 Visit 12 - Week 36 Visit 13 - Week 40 Visit 4 - Week 4 Visit 5 - Week 8 Visit 6 - Week 12 Visit 7 - Week 16 Visit 8 - Week 20 Visit 9 - Week 24 Procedures Total Quan tity Selected Cost Visit 1 - Screening Visit 2 - Day 1 Visit 3 - Week 1

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Budget Development Process

Read the protocol including footnotes in Schedule of Assessments Review the sponsors budget grid and payment terms Developing the internal study budget – Accounting for all costs Revise sponsors template based on the internal budget Justify costs

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Industry Sponsored Budget Components

Budget Components Non-Subject Fees/

  • Admin. Fees/

Contingent Fees (need to be invoiced) Subject Costs (may or may not need to be invoiced)

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Subject Costs

  • Determining research costs vs. standard of care (SOC)
  • PI should be determining what costs are SOC (not the sponsor)
  • If the PI would not typically order the procedure for a clinic patient (with

the same condition) then it would not qualify as SOC for the research subject.

  • Easiest method: Provide the schedule of assessments to PI and have the PI

highlight the items that are SOC

  • Verify what the SOC frequency is
  • The item may be SOC every 6 weeks but the study calls for the item

every 3 weeks

  • If insurance won’t cover the frequency needed, you need to negotiate

with the sponsor to ensure the sponsor will pay for what the insurance won’t

Determining Standard of Care is the First Step in Developing the subject budget

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SLIDE 10

Industry Sponsored Budget Components

Subject Costs Per Subject budget (Subject visits) Invoiced Subject Costs

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Subject Costs Per Subject Budget

Per Subject Budget Staff Costs (PI and coordinator) Procedures (NMHC & NMG) Labs Pharmacy (Dispensing) Subject Payments (Stipends) Overhead Invoiced Subject Costs

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Per Subject Budget

  • Estimating Coordinator Time
  • Protocol Required Activities
  • Informed Consent (estimated 3 hours)
  • Inclusion/Exclusion Criteria & Medical History
  • Questionnaires
  • Assessments
  • Additional time waiting for subject
  • eCRFs (electronic case report forms)
  • Estimated that for every 1 hour spent with subject there is 1.5 hours of paperwork
  • Subject Recruitment & Pre-screening
  • Scheduling
  • Regulatory Paperwork
  • Monitor Visits
  • What is the monitoring visit schedule
  • Remote monitoring still takes staff time
  • Estimated number of subjects
  • Remember: It always takes longer than you expect

Coordinator Costs

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Per Subject Budget

  • Options for accounting for coordinator time in budget
  • Percent Effort
  • Estimated number of hours per visit
  • Be sure to include administrative time for the coordinator
  • Estimated: For every 1 hour spent with a subject the

coordinator will spend approx. 1.5 hours on paperwork

  • Assigning dollar amounts to activities/assessments

Coordinator Costs

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SLIDE 14

Per Subject Budget

  • Percent Effort must be allocated to visits and number of subjects
  • Percent Effort Calculation
  • ((Salary + Benefits) * % effort)/# of anticipated subjects
  • This formula calculates the amount that needs to be included per subject.
  • The amount calculated is then allocated across the visits.
  • Be realistic on the number of anticipated subjects
  • If you base the calculation on more subjects then are actually

enrolled then the study will likely end in a loss.

Coordinator Costs –Percent Effort

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SLIDE 15

Per Subject Budget

  • Estimating PI Time
  • Physician Oversight
  • Review of Labs
  • Review of SAE’s
  • Exams
  • Physical Exams – Different for every department
  • Does the study include a full exam on some visits and a partial exam on other

visits?

  • Physical Exam costs (99201-99205, 99211-99215)
  • There are different rates for the first visit (new Subjects) and established

Subjects

  • Percent Effort
  • Be realistic on the percent effort
  • Assigning dollar amounts to activities/assessments

Physician Costs

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SLIDE 16

Per Subject Budget

  • CPT (Current Procedural Terminology) codes needed for

NMHC and NMG procedures

  • Account for both the technical fee and the professional

fee

  • Radiology
  • Does the CPT code include all of the images the

protocol requires?

  • Is a case rate needed?
  • Is the subject admitted?
  • Contact NMHC Office of Research
  • Be sure to use the current research chargemaster

(updated each fiscal year)

Procedure Costs (NMHC and NMG)

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SLIDE 17

Per Subject Budget

  • Central Lab
  • Who will be processing/shipping the samples?
  • Include estimated staff time to collect/process/ship samples
  • Local Lab
  • Prices in NM research price catalog
  • CPT code for tests is needed
  • The protocol may list a panel such as chemistry or hematology
  • This DOES NOT mean that it is the same as the panel at the site
  • Verify in the protocol what the sponsor is including in the panel and compare

to the labs included in the NMHC panel

  • Always include Phlebotomy fee for studies that have blood draws

Labs

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SLIDE 18

Per Subject Budget

  • Is there a subject stipend? How much is the stipend?
  • Is the amount coercive?
  • Confirm the amount in the budget matches the informed consent
  • The amount in the budget needs to include the 30% overhead.
  • If you see an amount in the budget of $65 (inclusive of overhead) that DOES match the consent because it is $50

that the subject is receiving

  • Is the sponsor directly paying the subject?
  • Gift cards provided by sponsor
  • Stipend amount does not need to be included in the subject
  • Is the site processing the payment?
  • If so then the indirect cost rate needs to be applied to the stipend
  • Can be used to cover:
  • Parking
  • Time
  • Meals
  • Extra stipend for long visits
  • Example: Timed PK draws
  • Extra stipend for visits with additional procedures
  • Example: MRI’s
  • Travel and stipend payments are subject to IRB approval
  • Must be included in the informed consent
  • Should not be coercive

Subject Stipend –Travel Reimbursement

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Per Subject Budget

  • Are you utilizing the investigational pharmacy?
  • There are costs for EVERY time the drug is dispensed by

the pharmacy

  • Even if you are not using the pharmacy to store the

drug there are still costs

  • If the department/coordinator is storing the drug
  • Include time for the coordinator to dispense drug
  • Include time for the coordinator if they have to account

for the Subjects compliance such as collecting the bottles and counting the # of missed doses

  • At the time of budget development the pharmacy

manual is typically not available. To determine the actual dispensing amount for injectables contact the pharmacy.

Pharmacy

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Per Subject Budget

  • Overhead is applied to ALL items in any Industry Sponsored

Budgets

  • NON-NEGOTIABLE
  • IRB fees are the only fees that DO NOT have indirects applied.
  • Double check advertising, subject stipends, and invoiced items to

ensure the sponsor will pay the overhead

  • Many sponsors consider these “flow-through” items

Overhead

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SLIDE 21

Subject Costs

  • Is sponsor only paying for procedures performed (prior to subject being

deemed a screen failure)?

  • Make sure staff time is included in the amount you will be paid
  • Is sponsor paying the full cost of the screen failure?
  • Ex: Sponsor will pay 80% of the screening visit for screen failures
  • Is there a ratio?
  • Ex: for every 3 patients randomized sponsor will reimburse 1 screen

failure

  • Is there a cap on screen failures?

Screen Failures

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SLIDE 22

Industry Sponsored Budget Components

Budget Components Non-Subject Fees/

  • Admin. Fees/

Contingent Fees (need to be invoiced) Subject Costs (may or may not need to be invoiced)

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SLIDE 23

Non-Subject Fees/ Admin. Fees/ Contingent Fees

Initial Fees

(exclusive of indirects) (inclusive of indirects) Comments Documentation to provide to Sponsor IRB Fees Initial IRB Review $2,500.00 No indirects Non-negotiable. Charged even if central IRB is being utilized https://irb.northwestern.edu/ab

  • ut/fees

IRB Annual Renewal/Closeout (each) $750.00 No indirects Pharmacy Fees Pharmacy Startup Fee $ 3,000.00 $ 3,900.00 If your study has investigational product the pharmacy fee should be included in the budget and non-negotiable. Have the sponsor complete the pharmacy worksheet. Pharmacy Worksheet Pharmacy Annual Maintenance (low) $ 300.00 $ 390.00 Pharmacy Annual Maintenance (med.) $ 700.00 $ 910.00 Pharmacy Annual Maintenance (high) $ 1,000.00 $ 1,300.00 Study Initiation Fee (Total $10,725) Initial Regulatory Preparation and Submission $3,250.00 $4,225.00 Covers the staff time associated with preparation/submission of IRB and regulatory documents CCR Memo (dated Sept. 19, 2016): FY 2017 Research Fees: One time fees for Industry Sponsored Research Coordinator Startup $1,000-$3,000 $1,300-$3,900 Covers the coordinator time associated with getting the study open. Amount depends

  • n what sponsor requires from coordinator.

Admin Startup $2,000.00 $2,600.00 Covers the staff time associated with budget development and negotiation

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SLIDE 24

Non-Subject Fees/ Admin. Fees/ Contingent Fees

Study Initiation Fee/Start-up Fee

Process What’s included Regulatory Interface with Study Team, Sponsor, CRO, and IRB of record; Manage IRB submission including follow-up comments and/or questions arising during approval process; Complete all FDA & Sponsor-required documents (i.e., 1572s, FDFs, CVs, CAP/CLIA); Create and maintain regulatory binder. Financial Coordinate charges between all procedural departments; Gather budget costs and finalize an approved negotiated budget; Handle contract paperwork; Open all study financial accounts. Study Coordination Attend all required protocol training and investigator meetings; Coordinate with various departments for study procedures; Prepare source documents; Organize the site initiation visit. Administrative Miscellaneous management, clerical, and administrative work needed to open the study.

The study initiation fee is $10,725 (inclusive of indirects) and covers the costs associated with the many processes and department services required for site initiation at Northwestern.

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SLIDE 25

Non-Subject Fees/

  • Admin. Fees/

Contingent Fees

  • The High Complexity ($3,000 exclusive
  • f indirects) is factored into the Study

Initiation Fee. The Study Initiation Fee can be lowered if the coordinator start- up is in one of the lower complexity levels.

  • For a copy of the CCR coordinator

startup fee questionnaire contact rena.carrizoza@northwestern.edu

Coordinator Startup Fee

Type of Study Phase I (4 points) Phase II (3 points) Phase III (2 points) Phase IV (1 point) Device (4 points) Typical Start-Up Activities Protocol Review 8 hours (8 points) Site Qualification Visit 2 hours (2 points) Site Qualification Visit 4 hours (4 points) Virtual Investigator Meeting 1 hour (1 point) Investigator Meeting 8 hours (8 points) Investigator Meeting 15 hours (≈2 days) (15 points) Site Initiation Visit 4 hours (4 points) Site Initiation Visit 6 hours (6 points) Site Initiation Visit w/certification or training 8 hours (8 points) Additional Start-Up Activities Equipment Provided by Sponsor 2 hours (2 points) CRU CRU Orders 4 hours (4 points) Coordinating with CRU Core Lab 1 hour (1 point) Coordinating with Diagnostic Testing Center 1 hour (1 point) DEXA/Olsen MRI Training 3 hours (3 points) Lurie Childrens or RIC (if needed) 4 hours (4 points) Total Points (add points from above): Start-up Level Complexity Scale: Low Complexity: 1-14 points $1,000.00 Medium Complexity: 15-28 points $2,000.00 High Complexity: 29-42 points $3,000.00

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SLIDE 26

Non-Subject Fees/ Admin. Fees/ Contingent Fees

Close-out Fees

(exclusive of indirects) (inclusive of indirects) Comments Documentation to provide to Sponsor Document Storage (up to 6 years) $1,000.00 $1,300.00 Review the CTA to find out how long the sponsor is requiring the study documents be stored. If no documentation available provide sponsor with a signed memo from the PI or chair Document Storage (up to 12 years) $1,500.00 $1,950.00 Document Storage (up to 18 years) $2,000.00 $2,600.00 Document Storage (up to 24 years) $2,500.00 $3,250.00 Document Storage (over 24 years) $3,000.00 $3,900.00 Study Close out $1,000.00 $1,300.00 Covers the coordinator time associated with closing out the study (closeout visit, clearing data queries, etc.) CCR Memo (dated Sept. 19, 2016): FY 2017 Research Fees: One time fees for Industry Sponsored Research

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SLIDE 27

Non-Subject Fees/ Admin. Fees/ Contingent Fees

(exclusive

  • f indirects)

(inclusive of indirects) Comments Documentation to provide to Sponsor IRB Annual Renewal/Closeout Prep Fee (each) $600.00 $780.00 Invoice per occurrence If no documentation available provide sponsor with a signed memo from the PI or chair Protocol Amendments/Preparation Fee (each) $500.00 $650.00 Invoice per occurrence

  • r

Annual Maintenance Fee ($1,000 Regulatory; $500- 1,500 Financial/Admin.) $2,500.00 $3,250.00 Invoiced annually at time of IRB renewal CCR Memo (dated Sept. 19, 2016): FY 2017 Research Fees: One time fees for Industry Sponsored Research

Maintenance Fees

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SLIDE 28

Non-Subject Fees/ Admin. Fees/ Contingent Fees

Maintenance Fees

  • The annual maintenance fee is $3,250 and is charged at the time of IRB renewal. This

fee covers the costs associated with study maintenance to ensure regulatory compliance including regulatory submissions for IRB periodic reviews and amendments, budget and contract amendments, and financial management of the study account.

Process What’s included Regulatory Protocol Amendments; Modifications to study documents including consent forms, IBs, recruitment materials; Personnel modifications; Continuing review/study closeout; Regulatory binder maintenance; Interface with study monitors, CRO, sponsor, and IRB; FDA document maintenance (1572, FDFs, CVs, etc.); Support for ClinicalTrials.gov. Financial Invoice; Track patient visits; Reconcile payments received; Provide updates

  • n study account status and accounts receivables; Process subject stipends

and NM invoices for payment; Assure billing compliance; Negotiate budget amendments (if needed).

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SLIDE 29

Non-Subject Fees/ Admin. Fees/ Contingent Fees

  • Recruitment activities extend beyond direct advertising
  • Database maintenance and searching
  • Telephone pre-screening
  • Preparation and placement of recruitment materials
  • Follow-up on subject referrals and chart reviews
  • Scheduling screening visits
  • Recruitment is often an unpaid cost
  • Negotiate to offset some of the cost of material development, non-

advertising recruitment activity and telephone pre-screening, particularly if site has dedicated recruitment staff

  • Request hourly reimbursement for prescreening to cover some of

the prescreening efforts Recruitment –Hidden Cost

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SLIDE 30

Non-Subject Fees/ Admin. Fees/ Contingent Fees

  • Advertising is Expensive
  • Try to get as much as you can
  • Add overhead
  • Only invoice if advertising actually occurred
  • If a site’s advertising strategy has been successful, the sponsor may

be willing to approve additional funds for advertising Advertising

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SLIDE 31

Budget Development

  • Most sponsors require documentation/justification of costs.
  • Links to documented rates/policies
  • IRB Fees
  • F&A rates
  • Memos (on letterhead)
  • Signed Letters (on letterhead)
  • Pharmacy Worksheet

Justify Costs

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SLIDE 32

Budget Development

  • As a non-profit institution, NU must recover the full cost of research

conducted for outside sponsors, including all associated operating costs (overhead). To do otherwise would result in subsidizing for-profit research and could jeopardize the institutions non-profit status.

Subsidizing for profit

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SLIDE 33

Budget Development

  • “Payments for research services should be fair market value for legitimate,

reasonable, and necessary services.” (HHS OIG, 2003 Notices) Promoting Objectivity in Research (CFR, Title 42)

  • Definition:

“The fair market value is the price at which the property would change hands between a willing buyer and a willing seller, neither being under any compulsion to buy or to sell and both having reasonable knowledge

  • f relevant facts.” (CFR, Title 26)

Fair Market Value

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SLIDE 34

Budget Development

Every contract will be different – with different terms – read the payment terms carefully

  • Payment Terms and Frequency
  • When will the sponsor make per Subject payments?
  • Quarterly?
  • After monitoring visits?
  • What triggers the payments?
  • eCRF completion?
  • Monitoring visits?
  • Invoice
  • Startup Fee
  • Does the original contract the sponsor sent state that ALL or a percent of the startup fee is refundable?
  • Does the original contract state when the startup fee will be paid?
  • Invoiced Items
  • What is the time frame for submitting invoices.
  • Screen Failures
  • Holdback

Important things to look for in the payment terms

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SLIDE 35

Useful Tips

  • Read the Protocol to determine expenses
  • DO NOT just create the budget from the study calendar (or the sponsors

budget draft).

  • Read through protocol text to ensure it matches the calendar.
  • Not all cost items are included in the schedule of assessments
  • Be flexible (if you can)
  • Sponsor may not be willing to add a fee that is titled a certain way but

they may be willing to offer something else that would cover the fee.

  • Determine what the sponsor is willing to pay

ALL RESEARCH COSTS MUST BE COVERED!!!

Budget Development

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SLIDE 36

Useful Tips

  • ALWAYS read the footnotes of the schedule of events
  • Beware of lab panels
  • If schedule of assessments or budget lists a lab panel check the protocol

to see what tests the protocol is included in the panel

  • Example: Comprehensive Chemistry Panel includes 14 tests, sponsors
  • ften include additional tests which will need to be accounted
  • Startup Fees should be non-refundable
  • Allow room for negotiation
  • Be flexible
  • Track the holdback so that you know what is due at termination
  • ALWAYS double check the formulas in the spreadsheet to ensure

ACCURACY

  • Make sure totals are correct

Budget Development

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SLIDE 37

Potential Causes for Delays

  • IRB Approval
  • OSR needs copies of the IRB approval letter and the approved ICF
  • COI clearance
  • Every study is reviewed for possible conflicts of interest
  • If there is a potential conflict the study may need to be reviewed at the monthly COI meeting
  • May require a change of PI if there is a conflict of interest
  • Device Committee Approval (If device study)
  • Every investigational device must be submitted to the device committee

and the committee will determine if a presentation at their monthly meeting is required

  • All approvals obtained on the InfoEd proposal
  • PI and dept. chair must approve the InfoEd proposal

Items necessary before CTA can be signed

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SLIDE 38

Budget Development

It is EXTREMELY important to review the details of the protocol and payment terms because once you have agreed to a budget and the contract is signed it is VERY difficult to get the sponsor to revise the budget. Double-Triple check your budget before sending to sponsor

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SLIDE 39

Review of Learning Objectives

  • Identify the components of a clinical trial budget
  • Identify hidden costs
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SLIDE 40

Thank You

3/21/2017

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Kelsey Richey | Financial Services Manager Center for Clinical Research (CCR) 750 N Lake Shore Drive, Rubloff 11th floor Chicago, IL 60611 kelsey.richey@northwestern.edu | Office: 312-503-2227

Questions