Case Study Protocol Template

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					         ICSSC
  International Clinical
Sciences Support Center

Family Health International




                              1
           What is the ICSSC?
   DMID contract for investigators funded by
    NIH/NIAID/DMID conducting research at
    resource-constrained foreign sites
   Located at Family Health International (FHI),
    a diverse public health research organization
    working mainly in the developing world.
   Composed of an interdisciplinary team of
    experts in various areas of clinical research.
        Who is the ICSSC?
                          Clinical
                           Trials/
                          Protocol
                         Specialists



  Logistics/
                                                 Data Managers
Event Planners
                          Who is
                        the ICSSC?



             Study
            Design/
                                       Biostatisticians
          Methodology
            Experts
           ICSSC Services
   Protocol Development
   Site Assessment
   Data Management
   Biostatistics
   Training
   Etc.
Where is the ICSSC?
      Requesting Assistance

   New ICIDR….need HELP?
    • Contact your DMID Program Officer
    • Contact the International Clinical
      Sciences Support Center (ICSSC)

     http://www.icssc.org/
        Study Protocol

ICH GCP 1.44:
  “A document that describes the
  objective(s), design, methodology,
  statistical considerations, and
  organization of a trial.”
    ICSSC Protocol Development
           Services (1)
   Protocol Pre-Review
    •   Clarity
    •   Completeness
    •   GCP compliance
    •   Proper use of DMID protocol templates
        http://www.niaid.nih.gov/dmid/clinresearch
          DMID Study Product Template

          DMID Specimen Protocol Template: Greater Than

           Minimal Risk
          DMID Specimen Protocol Template: Minimal Risk
    ICSSC Protocol Development
           Services (2)
   In-depth protocol review/assistance
    •   Study design consultation
    •   Statistical considerations
    •   Implementation planning
    •   Data management plans
    •   CRF development
    •   Safety reporting and monitoring
    •   Good Clinical Practices (GCP)
    •   Informed consent
    •   Protocol development coordination
         Process
 Choose the research question
              
     Develop the concept
              

 WRITE THE PROTOCOL
              
  Revise/finalize the protocol
(DMID and IRB approval crucial)
              
      Conduct the study
What To Consider When Writing
       The Protocol (1)
   Grant proposal vs. study protocol
   Narrow down specific aims to
    objectives
   Choose appropriate study
    design/protocol template
   Eliminate all non-applicable template
    language from the protocol (use
    working shell)
   Minimize duplication/ensure
    consistency
What To Consider When Writing
       The Protocol (2)
   Provide precise information on
    study population and case
    definitions
   List all inclusion/exclusion
    criteria
   Ensure objectives are linked to
    study procedures and statistical
    sections
What To Consider When Writing
       The Protocol (3)
   Include sufficient detail in protocol
    sections like
    • Study procedures
    • Data management
    • Statistical considerations/ analysis
    • Safety monitoring and reporting
    • Ethical considerations/ Human
      subjects protection
    •…
    What To Consider When Writing
           The Protocol (4)
   Keep up with informed consent
    issues
    • Informed consent(s) included?
    • Language simple?
    • Enough information about the research?
    • Sufficient description of all study visits,
      procedures, samples taken?
    • Required elements included?
    • Separate approval for future use
      specimen storage?
           Appendices

   Sample informed consent(s)
   Schedule of events/visits
   Product use directions
   Other special procedures
   (Data collection forms)
      Protocol Amendments

   Informed consent and
    protocol are usually approved
    together
   Any change to either
    document requires DMID and
    IRB review and approval
      Protocol Writing Tips (1)
   Use consistent formatting
   Include header/footer with version
    and date information
   Use reasonable margins
       “white space” eases readability
   Use numbered section, subsection
    titles
     Protocol Writing Tips (2)
   Spell out abbreviations (abbr.)
    and acronyms (acr.) at first use
   Spell out single-digit numbers up
    to nine
   Use bulleted lists instead of long
    paragraphs
   Avoid duplication of information
   Delete template sections, if not
    applicable
             Final Hints
   Clear, concise protocol critical to
    study success
   Start early —
    protocol development takes time
   Early input and internal peer
    review facilitates approval process
    later
   Expect multiple reviews —
    DMID, IRBs and possibly scientific
    committees generally provide
    comments
       Site Assessment Services
   Site assessment -   by investigator or
                        DMID request
    • Needs assessment with
      recommendations
    • Pre-monitoring assistance
    • Good Clinical Practices (GCP)
    • DM assessments
    • Clinical site, pharmacy, lab
    • IRB
    • Staff capabilities
    • Training
     Data Management Services
   Site Assessments
   Training
    • Investigator workshops
    • DM hands on workshop
    • At FHI
   Trial Support
    •   Data management plans
    •   CRF development
    •   Data entry systems
    •   Documentation and validation
ICSSC Biostatistics Services (1)
   Protocol
    development/implementation
    • Study design consultation
    • Endpoint definition
    • Sample size determination
    • Analysis plan development
    • DSMB plans
    • Randomization and allocation
      concealment procedures
ICSSC Biostatistics Services (2)
   Case report forms review
   DSMB
    • Interim report preparation
    • Independent Statistician
    Final data analysis and
    interpretation of results
   Preparation of final
    report/manuscripts
     ICSSC Training Services
   Regional clinical research workshops
    • Fundamentals of clinical research
   Data management workshops
   Individual data management training at
    FHI
   Ethics Training
   Scientific writing workshop
    • Assistance with data and manuscript
      preparation for publication.
   GCP training
   Study Implementation training
Tools & Resources:
  ICSSC website
   www.icssc.org
     Research Resources
     Presentations
     ICSSC Services
     Contacts
     Request for Assistance
          Tools & Resources:
                   WebEx
   Web-based meeting tool that allows
    participants to view documents, annotate
    documents, and perform demonstrations
    using a variety of software.
   Allows investigators to hold on-line
    meetings between team members located
    around the world.
   FHI provides international calling support
    in conjunction with WebEx and has
    created secure user accounts for all
    domestic and foreign PIs who have
    requested the use of WebEx.
             Summary

   ICSSC can provide support
    during protocol development as
    well as during the study
    planning and implementation
    phases
   Contact the ICSSC:
    http://www.icssc.org/

				
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Description: Case Study Protocol Template document sample