UW Research

Statistical Center for HIV/AIDS Research & Prevention (SCHARP)

http://www.scharp.org/index.html

Mission

Over the past 25 years, SCHARP has conducted more than 250 HIV prevention and vaccine studies in domestic and international sites. SCHARP and its partner SDMCs are currently managing nearly 90 phase I – III clinical trials, with more than 40 actively enrolling or following participants. The studies are being conducted at over 150 clinical sites in more than 25 countries around the world.

Established in 1992 to support global HIV prevention research at Fred Hutch, we have since expanded to support additional therapeutic areas including oncology and other infectious diseases. SCHARP operates according to all national and international regulatory standards. Our team with over 150 clinical trials specialists are skilled in biostatistics, programming, IT data systems, quality assurance, project management and clinical and lab data management collected from multiple sources worldwide.

Core Services Offered

SCHARP supports clinical researchers and administrators with high quality clinical and laboratory data management and statistical services.

Clinical Data Management

  • Data collection system support and development
  • CRF definition and development
  • EDC programming
  • Data management plan creation and maintenance
  • Data quality monitoring and discrepancy resolution
  • Clinical safety monitoring
  • Adverse event and drug coding
  • Site training and support

Laboratory Data Management

  • Data collection and management of lab assay data used for immunogenicity, adherence, pharmacokinetics, and diagnostics
  • New experimental assay expectations and data format development
  • Specimen monitoring and tracking
  • Lab data transfer support from local and central labs
  • Quality assurance and processing of lab data
  • Reconciliation of lab data with clinical data
  • Assay data processing

Programming and Information Technology Services

  • Validated 21 CFR Part 11 compliant systems
  • Software development
  • IT system security, support and administration
  • IT infrastructure development
  • CDISC data standards
  • Clinical trial report development
  • Operational and statistical programming and reporting
  • Data archiving

Statistics

  • Statistical study design
  • Sample size and power calculations
  • Statistical analysis plan creation and maintenance
  • Randomization planning and operations
  • Data and safety monitoring reports and support
  • Endpoint adjudication support
  • Interim study analysis
  • Final statistical analysis and study reports
  • Manuscript and abstract analysis, writing, and support
  • IND reports
  • Data dissemination

Quality Assurance and Regulatory Compliance

  • Quality Management System
  • SOP creation and management
  • Document Control
  • Training records
  • Event reporting and CAPAs