study budgets: industry sponsored studies...nmg (professional fees) subject stipend. pharmacy....

Study Budgets: Industry Sponsored Studies

Kelsey RicheyCenter for Clinical Research (CCR)

Learning Objectives

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

Topic Overview

• Budget Development Basics• Components of a Clinical Trial Budget

- Subject Costs- Non-Subject Fees/ Admin. Fees/ Contingent Fees

• Useful Tips

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

Budget Development BasicsExample Internal Budget (see sample legal size template)

Center for Clinical Research (CCR) Financial Services ProgramInvestigator: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 XElizabeth Kidd, 5% Effort Demography, Height X

Medical history XMS History/Treatments XIncl/Excl X XPhone interview X X X X X X XPatient diary review X X XContraception status X X X X XVital signs, Weight X X X X X X X XPrior/Con Meds X X X X X X X XeCSSRS X X X X X X X XT25FW X X X X X9HPT X X X XSDMT X X X XMSIS-29 X X X XEQ-5D X X X XWPAI:MS X X X XPRO 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 3.0Per 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 XPregnancy 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 Budget7-Jul-2016

$3,888.29

2.5

3%

$7,276.39

Coordinator Time/Effort

PI (& Sub-I) Time/Effort

NMG (Professional Fees)Subject Stipend

PharmacyOverhead

NMHC (Hospital Fees)

Labs

Budget Development BasicsExample Sponsor Budget (Every Sponsor will have a different template)

Coordinator Time/Effort

PI (& Sub-I) Time/Effort

NMG (Professional Fees)Subject Stipend

PharmacyOverhead

NMHC (Hospital Fees)

Labs

1.00 150.00 150.00 150.001.00 215.00 215.00 215.001.00 180.00 180.00 180.00

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 25.00 325.003.00 125.00 125.00 125.00 125.00 375.00

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 35.00 560.0013.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 400.00 5,200.0016.00 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 1,440.004.00 300.00 300.00 300.00 300.00 300.00 1,200.004.00 115.00 115.00 115.00 115.00 115.00 460.00

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 1,760.0028.00 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 2,464.0028.00 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 2,520.0015.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 1,500.0012.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 20.00 240.005.00 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 50.00 800.001,518.00 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 5,861.701,973.40 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 2,080.0016.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 165.00 2,640.0013.00 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 20.00 260.0016.00 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 5,780.0030.00% 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

1.00 650.00 650.001.00 1,000.00 1,000.001.00 5,000.00 5,000.00

Each Year

750.00

1.00 750.00 750.001.00 5,000.00 5,000.00 1.00 3,900.00 3,900.00

Each Year

910.00

Each Year

75.00

Each 2,421.902.00 39.00 78.00

13.00 20.00 260.00

Annual Pharmacy Fee

SAE report prep fee

Screen Failure

Site Start-up CostsInitial 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 CostsSalaries: 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, QuantitativeUrine Pregnancy Test, Qualitative

Adverse Events AssessmentPer Patient Procedure:Overhead at

Per Patient Procedure Subtotal:

Cost Per Patient Totals:

Invoice ItemsName Total

QuanSelected Cost

Total

Per Patient Other Direct Cost Totals:

Archiving/Document storage/per site

Initial IRB FeeIRB Renewal

Urinalysis

ECGReview Concomitant MedicationsIntravitreal Injection of REGN2176-3 Or BCVAFluorescein AngiographyFundus PhotographySD-OCTOcular Blood Flow by Repetitive IOPIndirect OphthalmoscopySlit LampVenipuncture/Sample Handling

Visit 16 - Week 52 (End

of Study)

Total

Informed ConsentComplete 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 Quantity

Selected

Cost

Visit 1 - Screening

Visit 2 - Day 1

Visit 3 - Week 1

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

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)

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


Subject Costs

Per Subject budget

(Subject visits)

Invoiced Subject Costs

Subject CostsPer Subject Budget

Per Subject Budget

Staff Costs(PI and coordinator)

Procedures (NMHC & NMG)

Labs

Pharmacy (Dispensing)

Subject Payments (Stipends)

Overhead

Invoiced Subject Costs

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

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

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

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

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)

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

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

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

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

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


Budget Components

Non-Subject Fees/ Admin. Fees/

Contingent Fees(need to be invoiced)

Subject Costs (may or may

not need to be invoiced)

Non-Subject Fees/ Admin. Fees/ Contingent FeesInitial Fees

(exclusive of indirects)

(inclusive of indirects) Comments Documentation to provide to

Sponsor IRB FeesInitial IRB Review $2,500.00 No indirects

Non-negotiable. Charged even if central IRB is being utilized

https://irb.northwestern.edu/about/feesIRB 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-$3,900Covers the coordinator time associated with getting the study open. Amount depends on what sponsor requires from coordinator.

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

https://irb.northwestern.edu/about/fees

Non-Subject Fees/ Admin. Fees/ Contingent FeesStudy 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.

Non-Subject Fees/ Admin. Fees/ Contingent Fees

• The High Complexity ($3,000 exclusive of 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 [email protected]

Coordinator Startup Fee

Type of StudyPhase 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 ActivitiesEquipment 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 $1,000.00Medium Complexity: 15-28 points $2,000.00High Complexity: 29-42 points $3,000.00

mailto:[email protected]

Non-Subject Fees/ Admin. Fees/ Contingent FeesClose-out Fees


(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 (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



(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 chairProtocol Amendments/Preparation Fee (each)

$500.00 $650.00 Invoice per occurrence

or

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

Non-Subject Fees/ Admin. Fees/ Contingent FeesMaintenance 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 on study account status and accounts receivables; Process subject stipends and NM invoices for payment; Assure billing compliance; Negotiate budget amendments (if needed).


• 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


- 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

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

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

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 of relevant facts.” (CFR, Title 26)

Fair Market Value

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

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 payALL RESEARCH COSTS MUST BE COVERED!!!

Budget Development

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 often 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

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

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

Review of Learning Objectives

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

Thank You

3/21/2017 40

Kelsey Richey | Financial Services ManagerCenter for Clinical Research (CCR) 750 N Lake Shore Drive, Rubloff 11th floor Chicago, IL 60611 [email protected] | Office: 312-503-2227

Questions

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