Evaluation of a Protocol Budget

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					Evaluation of a Protocol Budget

        Margaret Matula, R.N., M.G.A.
                    Branch Chief
     Clinical Research Management Branch
        Therapeutics Research Program
                  Division of AIDS
National Institute of Allergy & Infectious Diseases
           National Institutes of Health



DHHS/NIH/NIAID/DAIDS               IPPCR 2/8/05 Slide # 1
                 Introduction


 Determine:
   Protocol requirements
   Site resource requirements
 Establish protocol budget




DHHS/NIH/NIAID/DAIDS            IPPCR 2/8/05 Slide # 2
                Requirements


   Duration
                        Laboratory
   Subjects
                        Study Product
   Screening
   Clinical            Toxicity
     Location          Data
     Infrastructure


DHHS/NIH/NIAID/DAIDS           IPPCR 2/8/05 Slide # 3
                Requirements


  Monitoring           Supplies
  Meetings             Institution
     Travel            Subcontracts
  Personnel            Indirect Costs
  Equipment            Other


DHHS/NIH/NIAID/DAIDS           IPPCR 2/8/05 Slide # 4
 Protocol Requirements — Duration


  On-study treatment / therapy

  Follow-up




DHHS/NIH/NIAID/DAIDS     IPPCR 2/8/05 Slide # 5
 Protocol Requirements — Subjects

  Enrollment

  Screening

  Eligibility Criteria

  # of Visits



DHHS/NIH/NIAID/DAIDS      IPPCR 2/8/05 Slide # 6
   Site Requirements — Subjects


  Population Base
        Size
        Racial / Ethnic minorities
        Women
        Children
        Other special populations


DHHS/NIH/NIAID/DAIDS            IPPCR 2/8/05 Slide # 7
          Subjects continued…


  Community Advisory Boards
      Financial support
      Educational forums
      Input / Perspective




DHHS/NIH/NIAID/DAIDS         IPPCR 2/8/05 Slide # 8
          Subjects continued…


  Outreach and Recruitment
      Strategy / Plan
        women & minorities
      Advertising
        primary care providers
        posters
        mailings

DHHS/NIH/NIAID/DAIDS        IPPCR 2/8/05 Slide # 9
          Subjects continued…

  Retention
      Strategy
      Tracking
      Incentives
         travel
         pain
         childcare
         sustenance
DHHS/NIH/NIAID/DAIDS      IPPCR 2/8/05 Slide # 10
Protocol Requirements — Screening


 Clinical Evaluations

 Laboratory Evaluations

 Time Constraints



DHHS/NIH/NIAID/DAIDS       IPPCR 2/8/05 Slide # 11
  Protocol Requirements — Clinical

  Study Visits
      # and length
        Staff expertise
        Exams / Evaluations
  Special Procedures
      # and type


DHHS/NIH/NIAID/DAIDS      IPPCR 2/8/05 Slide # 12
      Site Requirements — Clinical


    Radiology
    Special Procedures
    Inpatient
    Other units




DHHS/NIH/NIAID/DAIDS      IPPCR 2/8/05 Slide # 13
   Site Requirements — Location


  # of Clinics
      Single / Multi-site
  Urban / Rural
  Domestic / International
  University / Private Clinic



DHHS/NIH/NIAID/DAIDS         IPPCR 2/8/05 Slide # 14
Site Requirements — Infrastructure

  Existing Space
    Clinical
    Laboratory
    Office
    Other units
  Renovations / Alterations
  Consistent

DHHS/NIH/NIAID/DAIDS     IPPCR 2/8/05 Slide # 15
Protocol Requirements — Laboratory

  Tests: # and type
  Specimens
      Processing
      Shipping
      Storage
  Location: local, commercial, central
  Serial studies

DHHS/NIH/NIAID/DAIDS        IPPCR 2/8/05 Slide # 16
   Site Requirements — Laboratory

  Specimen Preparation
      Serum, Plasma, Cells, Tissue
  Shipping
      Packing materials, dry ice
      Transportation
  Storage
      Freezer space
      Tracking & retrieval
DHHS/NIH/NIAID/DAIDS          IPPCR 2/8/05 Slide # 17
Protocol Requirements — Study Product



   Administration of drug / agent
   # of drugs / agents involved
   Route




 DHHS/NIH/NIAID/DAIDS     IPPCR 2/8/05 Slide # 18
Site Requirements — Study Product

    Management
    Storage
    Accountability
    Subject




DHHS/NIH/NIAID/DAIDS   IPPCR 2/8/05 Slide # 19
  Protocol Requirements — Toxicity

  Treatment & Evaluation
     Additional Visits
     Additional Labs
  Reporting
  Follow-up



DHHS/NIH/NIAID/DAIDS        IPPCR 2/8/05 Slide # 20
    Protocol Requirements — Data

  Case Report Forms (CRFs)
      Development / Programming
  Amount collected per visit
      # Forms
      # Pages
  Time Constraints
  Quality Management

DHHS/NIH/NIAID/DAIDS      IPPCR 2/8/05 Slide # 21
Site Requirements — Data Management

   Staff
       Entry
       Management
       Quality Control & Assurance
   Equipment
       Computers
       Fax
       Copier
 DHHS/NIH/NIAID/DAIDS        IPPCR 2/8/05 Slide # 22
Protocol Requirements - Monitoring

  Clinical
      Adherence to protocol
      Adherence to regulatory & GCP
  Safety
      SAE reporting
  Data
      Source documentation

DHHS/NIH/NIAID/DAIDS          IPPCR 2/8/05 Slide # 23
 Protocol Requirements — Meetings


  Length, Location, #
        Investigator
        Coordinator
        Committee
        DSMB




DHHS/NIH/NIAID/DAIDS     IPPCR 2/8/05 Slide # 24
      Site Requirements — Travel


  Meetings
  Presentations
  Field
      Other sites
      Outreach



DHHS/NIH/NIAID/DAIDS     IPPCR 2/8/05 Slide # 25
  Site Requirements — Personnel


 Experience
 Commitments
    Other research
    Faculty
    Attending



DHHS/NIH/NIAID/DAIDS   IPPCR 2/8/05 Slide # 26
         Personnel continued…


   Investigator
   Coordinator
   Research Nurses
   Lab Scientists / Technicians
   Data Staff: entry, analyst, manager
   Statistician

DHHS/NIH/NIAID/DAIDS       IPPCR 2/8/05 Slide # 27
         Personnel continued…


 Clinical:
      Physicians
      Mid-level providers
      Nurses
      Pharmacist
 Specialists / Consultants


DHHS/NIH/NIAID/DAIDS         IPPCR 2/8/05 Slide # 28
         Personnel continued…


   Social Worker
   Monitor
   Quality Management
   Regulatory
   Administrators: Fiscal, secretarial
   Other

DHHS/NIH/NIAID/DAIDS        IPPCR 2/8/05 Slide # 29
   Site Requirements — Equipment

  Clinical
  Laboratory
      Freezers
      Centrifuge
  Office
      Computers
      Furniture
      Filing cabinets

DHHS/NIH/NIAID/DAIDS     IPPCR 2/8/05 Slide # 30
     Site Requirements — Supplies


    Clinical
    Laboratory
    Office
    Mailing / Shipping
    Phone / Fax


DHHS/NIH/NIAID/DAIDS      IPPCR 2/8/05 Slide # 31
     Site Requirements - Institution


 Institutional Review Board (IRB)
 Policies & Procedures
 Regulatory
     Federal
     NIH Policies
     Good Clinical Practice (GCP)


DHHS/NIH/NIAID/DAIDS        IPPCR 2/8/05 Slide # 32
 Site Requirements — Subcontracts

    Other Sites
    Monitoring
    Pharmacy
    Laboratory
    Data Management
    Record Storage


DHHS/NIH/NIAID/DAIDS   IPPCR 2/8/05 Slide # 33
Site Requirements — Indirect Costs

 Facilities & Administration
     Overhead
       utilities
       cleaning
       maintenance
     % of direct costs
       personnel
       equipment
DHHS/NIH/NIAID/DAIDS      IPPCR 2/8/05 Slide # 34
                       Other
 Protocol Requirements
   Study Management
        Site
        Overall
    Miscellaneous
 Site Resource Requirements
    Statistical Analyses
    Equipment Maintenance
DHHS/NIH/NIAID/DAIDS           IPPCR 2/8/05 Slide # 35
DHHS/NIH/NIAID/DAIDS   IPPCR 2/8/05 Slide # 36
   Establishing a Protocol Budget

  Information for prices / costs
      Experience
      Industry standard
      ?
  Include
      Start-up
      Screening & Follow-up
      Close-out
DHHS/NIH/NIAID/DAIDS       IPPCR 2/8/05 Slide # 37
 Establishing a Budget continued…


 Conserve costs while preserving
  safety and scientific integrity
     Necessary
     Negotiate rates
     Subcontract



DHHS/NIH/NIAID/DAIDS    IPPCR 2/8/05 Slide # 38
 Establishing a Budget continued…

 Determine how costs will be charged
   Personnel
     hourly rate
     % time & benefits
     per study visit
   Labs
     real time / batched
     storage
DHHS/NIH/NIAID/DAIDS        IPPCR 2/8/05 Slide # 39
 Establishing a Budget continued…



       Determine the REAL cost of
          conducting a protocol




DHHS/NIH/NIAID/DAIDS      IPPCR 2/8/05 Slide # 40
 Establishing a Budget continued…


  Line item for each resource
  Cost per patient
      Spreadsheet
      Subtotal categories




DHHS/NIH/NIAID/DAIDS         IPPCR 2/8/05 Slide # 41
                       Summary

 Protocol Requirements
    Schedule
    Conserve costs
     preserve safety & science
     necessary not interesting
 Site Resource Requirements
    Establish costs
    Spreadsheet
DHHS/NIH/NIAID/DAIDS             IPPCR 2/8/05 Slide # 42
                       Contact


                  Margaret Matula

        e-mail: mmatula@niaid.nih.gov

             phone: (301) 402-2302




DHHS/NIH/NIAID/DAIDS                IPPCR 2/8/05 Slide # 43

				
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