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Department of Neurology

Services Offered

Protocol Development

  • Study Design
  • Eligibility criteria definition
  • Primary endpoint definition
  • Sample size
  • Timetables
  • Scheduling of assessments and visits
  • Site review and selection
  • Model consent forms
  • Safety and efficacy monitoring
  • Detailed operations manuals
  • SOP development
  • Pharmacoeconomic outcomes
  • Quality-of-Life Measurements
  • Recruitment/Retention

Electronic Data Capture (EDC)

  • Content development
  • Efficient data entry design
  • Case report forms production
  • Packaging and distribution to sites
  • Computer application to track forms received
  • Tracking of forms in the database

Database Design & Management

  • Development of relational database structure
  • Capabilities for electronic transfer of data
  • Hard copy transfer of research study site data
  • Monitoring of keypunch format and range validations
  • Error identification and correction processes

Research Study Site Monitoring

  • On-site monitoring of facilities, case report forms, and source documentation, including reviews of: adequacy of patient and study facilities; drug dispensing, accountability and storage; protocol, case report forms, laboratory procedures, adverse event reports, medical records (source) documentation, informed consents and study file
  • Case review by medical staff
  • Guidance by safety monitoring committee

Administrative Services

  • Establishment of subcontracts with principal investigators and their participating research sites
  • Compliance with ICH, federal and pharmaceutical regulatory requirements and guidelines
  • Fiscal management of grant contractual and subcontractual agreements
  • Development and administration of research study budgets
  • Coordination of investigator/coordinator and steering committee meetings
  • Management of multi-center investigator groups

Reporting Services

  • Preparation of manuscripts for peer-reviewed publication
  • Preparation of regulatory reports


  • Consultation on protocol design/end point selection/analysis
  • Basic study design
  • Sample size/power calculation
  • Randomization plan
  • Primary/secondary outcome variables
  • Establishment of stopping guidelines for safety monitoring
  • Management, maintenance, and quality control of analytic database
  • Data management for study drug compliance and other blinded data
  • Data analysis and reporting
  • Data mining services
    • Organizing and combining completed trial data
    • Mining data to answer new research questions
    • Consulting

Clinical Materials Services Unit (CMSU)

  • Unit-dosing packaging
  • Labeling or re-labeling of drug to maintain blindedness
  • Protocol-specific computerized drug inventory and shipping schedules for research study sites
  • Quality Control

Specimen Repository

  • Cerebrospinal fluid
  • DNA
  • Tissue