Clinical trials 1
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Clinical Trials 1. Darlene Kitterman, MBA, Director, Investigator Support & Integration Services (ISIS), Oregon Clinical & Translational Research Institute (OCTRI). Audience.

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Clinical Trials 1

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Clinical Trials 1

Darlene Kitterman, MBA, Director,

Investigator Support & Integration Services (ISIS), Oregon Clinical & Translational Research Institute (OCTRI)


Audience

  • This course is intended for “department administrative staff”—including clinical research coordinators, department administrators, division managers, department fiscal managers, department effort coordinators, etc.


Introduction

  • This course follows the financial life cycle of a clinical trial up to clinical trial implementation:

    • Policies and guidance

    • Budget preparation

    • Payment schedules

    • Set-up of Accounts

    • Third party payer approvals


What is a Clinical Trial at OHSU?

  • Clinical Drug/Device Investigation

    • Mission code 54

    • A study of a drug (device, or diagnostic) where it “…is administered or dispensed to, or used involving, one or more human subjects.” and is a "prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical...interventions (drugs,... devices, or new ways of using known drugs...or devices).”

    • Translation: A drug or device intervention into a person


Clinical Trial FinancialPolicies and Guidance

  • Research Study Rate Request, Account(s) Setup And Billing Of Clinical Services (ADM 05.17)

  • Charges For Research Support (ADM 2.17)

  • Use of Devices in Patients and Research Subjects (ADM 05.18)

  • Sponsored Projects Budgets and Cost Coverage (No. 04-40-020)

  • ORIO Enrollment Incentive Policy

  • Research Documentation in the Integrated Health Record (HC-CLN-IHR-P005)


Clinical Trial Financial Tools

  • OHSU Hospitals and Clinics Research Rates, Accounts, Registration, Admission, and Charging Processes and FormsWebpage: http://ozone.ohsu.edu/research/rates/index.shtml

  • Clinical Trial Budget Templates

    • Industry: http://ozone.ohsu.edu/research/rates/budget_template.xls

    • Federal: http://ozone.ohsu.edu/research/rates/federalbudget.xls

  • Clinical Trial Budget Checklist: http://www.ohsu.edu/research/crp/docs/budgetchecklist.doc

  • OHSU Hospital Services Charging Process For Research Studies: http://ozone.ohsu.edu/research/rates/researchaccount.pdf

  • Clinical Study Billing Table: http://ozone.ohsu.edu/research/hscs/billingtable.doc

  • Medicare Advantage Tools:

    • http://ozone.ohsu.edu/research/rates/Medicare_Advantage_Patient_Handout.pdf

    • http://ozone.ohsu.edu/research/rates/Procedure_to_assign_guarantor.pdf


Budget Preparation

  • Analyze costs

    • Identify standard of care vs. research procedures

    • Minimum: all research costs must be covered

      • All tests and procedures

      • Salary support (investigator, study coordinator, other)

      • Professional fees (if not already getting salary support)

      • Other invoicable costs (informed consent translation, IRB initial and continuing review fees*, pharmacy**, shipping, storage, subject reimbursement, supplies, advertising, etc.)

    • If clinical services, complete Clinical Study Billing Table

      • Submitted with to IRB with application

      • Submitted to PBS with Research Rates Request Form

        *Required if industry sponsored, **Required if study of drug


Budget Preparation

  • Determine rates

    • Hospital Services

      • Technical Fees

        • Obtain from Clinical Department Contact or Research Rates Database

        • Federal:

          • Must use research rate

          • Hospital price X Research Rate % = Research price

        • Industry sponsored:

          • Budget for full price if possible

          • Will be charged research price (see below)

        • Budget for ~10% increase per year

        • Route Research Rate Request Form to obtain research rate (DHHS negotiated rate)

      • Professional Fees

        • Obtain from Clinical Department Contact or Research Rates Database

        • Standard discount ($75/RVU) reflected in database

        • Invoice from UMG reflects discount


Budget Preparation

  • Determine rates (cont.)

    • University service

      • Service center rate

      • Contact manager of service center

    • Outside vendor

      • Commercial vendor services: Agreement through Logistics

      • Outside organization involved in study: Subcontract through RGC

  • Apply Correct Indirect Cost Rate (IDC)

    • Industry: 25% Total Cost

      • 20% institutional F&A

      • 5% Department Assessment

        • Some departments don’t assess, stays in account

        • Some departments assess more, must add line item in budget

        • Some divisions assess in addition to department assessment, must add line item in budget

    • Non-industry: 33.5% Modified Total Direct Cost, excludes

      • Patient care costs

      • Equipment

      • Tuition, etc.


Unallowable Costs

  • Industry

    • Finders fees

    • Referral fees

    • Enrollment incentives

  • Federal

    • All industry unallowable above

    • Also unallowable costs per A-21

      • Administrative

      • Preparatory to research , etc.


Industry Sponsored Clinical Trial Payment Schedules

  • Specified in contract text or budget

  • Assure appropriate payment milestone and schedule used (based on work performed)

    • Visits performed

    • Visit CRFs collected

    • Patients enrolled

    • Patients completed

    • Study milestones


Industry Sponsored Clinical Trial Payment Schedules

  • Should not accept long intervals without payment (not > quarterly)

  • Should not accept withhold of large % at end of study (not >20% of study budget)

  • If milestone tied to monitoring:

    • Need to specify monitoring frequency

    • Need to include ability to get paid if monitoring outside of specified frequency

  • Include penalties for late payment (10% for > 60 days)


Industry Sponsored Clinical Trial Payment Schedules

  • Negotiate upfront payments

    • Nonrefundable for study preparation

      • IRB preparation

      • IRB review fee ($2,200, required)

      • Contract preparation

      • Budget preparation

      • Advertising (if applicable)

      • Pharmacy set-up (required if involves a drug)

    • Refundable: negotiated amount up-front to avoid deficit spending (usually number of patient visits)


Industry Sponsored Clinical Trial Payment Schedules

  • Other payments to include

    • Screen failure payment if expensive screening procedures

    • Event based costs invoiced to sponsor

      • IRB Project Revisions and Amendments ($825, required)

      • Continuing IRB Review ($1,320, required)

      • Pharmacy maintenance fees (if not in per patient budget)

      • Government audits

      • Record storage

      • SAE report preparation (if many and not included in per subject budget)

      • Subject compensation and/or expenses (if applicable)

      • Advertising costs (if applicable)

      • Translation expense (if applicable)


What to do with the Budget

  • Grant

    • Enter information into applicable format (ex: PHS398, SF424, etc.)

    • Append to grant or contract per instructions


What to do with the Budget

  • Industry Sponsor (cont):

    • Calculate detailed budget to determine actual costs

    • Determine budget with sponsor

      • Line item budget options

        • Complete worksheet provided by sponsor

        • Create budget and give to sponsor

        • Sponsor proposes line item budget

          • If covers cost per actual budget, agree

          • If doesn’t cover cost per actual budget, negotiate

          • Make changes to sponsor budget once agreed upon

      • Fixed price budget (per patient or per visit)

        • If covers cost per detail budget, agree

        • If doesn’t cover cost per detailed budget, negotiate


What to do with the Budget

  • Industry Sponsor (cont.)

    • Sponsor budget attached to contract

      • Line item budgets usually an appendix, fixed price budgets often in the text of the contract

      • If not in the contract, not obligated to pay

      • Changes must be renegotiated and appended to contract

        • Increased costs

        • Number of subjects

        • Extended term

      • Send final budget to contract analyst


Prestudy Support

  • Clinical Trials Office (CTO) Prestudy Unit: If industry sponsored, the CTO can do your budget (and IRB submission, and account requests) for you!

    • Paid by sponsor

    • http://www.ohsu.edu/research/crp/cto/index.shtml

  • Investigator Support & Integration Services (ISIS): Can assist with non-Industry clinical research budgeting and regulatory submissions

    • First clinical research grant: FREE

    • Funded investigator: Fee depending on service

    • http://www.octri.org/octri/public/index.aspx?pageid=76&siteid=1&menuid=18&siteid=1&siteid=1&MenuSelectedIndex=1

  • Contact Bridget Adams, Manager, 4-5077


Tracking Your Award

  • Track preaward process through set-up via “The Jellyfish”: http://rishtmldb.ohsu.edu:7042/pls/risprod/f?p=132:1:14251149068476920202

    • Which office is handling your study

    • Which analyst is responsible

    • Status


OGA Account Set-Up

  • Award Packet transferred to Sponsored Projects Administration (SPA) from preaward office

    • Industry Sponsored:

      • Contract executed

        • After all compliance approvals

        • After receipt of final budget from study team or sponsor

      • Contract copy sent to PI and Study Coordinator

    • All other:

      • Award notice received from funding agency

      • All DAC items completed


OGA Account Set-Up

  • Set-up Process Overview

    • Award and Project(s) set up in OGA

    • Notice of Acceptance (NOA) sent to Principal Investigator (PI) and “Award/Project Dept Fiscal Manager” with OGA Project Number and Alias

    • Timeline

      • 5 business day target – from receipt of account setup packet in SPA to NOA email to PI

      • In future, industry sponsored clinical trials: 24 hours to receipt of abbreviated NOA with OGA alias

  • Information on OGA account set-up:

    • Account Set-Up Process Flowchart: http://www.ohsu.edu/research/rda/spa/docs/applic1.pdf

    • More details available in SPA 101 course


Industrial Account Setup

  • Required if charging hospital services to a research account

  • Complete Research Rate Request and submit to Patient Business Services (PBS)

    • Can be completed as soon as study procedures determined

    • Includes:

      • Research Rate Request Form (p. 1 always required, p.2 required only if study services billed to the subject)

      • Protocol/research plan

      • IRB Lay Language Summary

      • Copy of Clinical Study Billing Schedule from IRB IRQ

    • Signature from all OHSU departments providing clinical services for study


Industrial Account Setup

  • Complete Industrial Account Request Form and submit to PBS

    • After receive OGA Project Number

    • Research Rate Request must have been submitted

    • An industrial account for a different study may NOT be used while waiting for a new account number


Medicare Approval for Devices

  • Applies to:

    • Category A devices for “life-threatening conditions”

    • Category B devices

    • Humanitarian Use Devices (HUD/HDE)

  • Must obtain approval from Medicare prior to using device in Medicare patients

  • HDEs also require patient specific approval (will be contacted by Melanie Hawkins, Clinical Research Billing Manager when Medicare approval for the HDE obtained)


Medicare Approval for Devices

  • After:

    • IRB approval

    • Contract negotiation complete or grant awarded, if applicable

  • Complete OHSU Investigational and Humanitarian Device Medicare Pre-Approval Form

  • Obtain signatures of PI on letter and certification

  • Send to Melanie Hawkins, Clinical Research Billing Manager

  • Wait for Medicare approval


Tips to Assure Correct Billing

  • Complete Research Rate Request form early and involve all Hospital Departments providing services

  • Use paper order form (downtime slip) to order services directed to the industrial account

  • If OHSU clinical services performed for research purposes:

    • Obtain an medical record number (MRN) for all subjects, even if not an OHSU patient

    • Create research FYI after subject signs informed consent form

  • If study involves standard of care clinical procedures

    • Participation in clinical trial must be preauthorized with private insurers

    • If subject enrolled in Medicare Advantage Plan services must be billed to traditional Medicare

      • Potential significant financial impact to subject, must be informed

      • Need to inform registration (email reghelp and Melanie Hawkins)

  • Register/admit subjects appropriately

    • Inpatient: Use Request for Research Subject Admission Form

    • Outpatient: If scheduling subjects in Cadence for research related visit:

      • Make sure research visit type utilized if visit for research purposes only (no standard of care), provide scheduler with industrial account number

      • If includes standard of care, should be regular clinical visit


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