ICSSC International Clinical Sciences Support Center

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ICSSCInternational Clinical Sciences Support
Center

• Family Health International

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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.

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Who is the ICSSC?
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ICSSC Services

• Protocol Development
• Site Assessment
• Data Management
• Biostatistics
• Training
• Etc.

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Where is the ICSSC?
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Requesting Assistance

• New ICIDR.need HELP?
• Contact your DMID Program Officer
• Contact the International Clinical Sciences
  Support Center (ICSSC)http//www.icssc.org/

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Study Protocol
ICH GCP 1.44A document that describes the
objective(s), design, methodology, statistical
considerations, and organization of a trial.
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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

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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

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Process
Choose the research question ? Develop the
concept ? WRITE THE PROTOCOL ? Revise/finalize
the protocol (DMID and IRB approval
crucial) ? Conduct the study
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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

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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

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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
  

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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?

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Appendices

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

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Protocol Amendments

• Informed consent and protocol are usually
  approved together
• Any change to either document requires DMID and
  IRB review and approval

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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

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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

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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

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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

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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

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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

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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

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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

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Tools ResourcesICSSC websitewww.icssc.org

• Research Resources
• Presentations
• ICSSC Services
• Contacts
• Request for Assistance

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Tools ResourcesWebEx

• 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.

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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/