About SCHARP

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

About Us

The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) at Fred Hutchinson Cancer Research Center consists of approximately 120 staff collectively skilled in clinical and lab data management, programming, statistics, IT data systems, quality assurance, and project management. SCHARP members strive to maintain a world-class statistical and data management center dedicated to improving global human health.  SCHARP provides clinical data management and statistical services that meet or exceed all sponsor, partner, and regulatory requirements and applicable international standards.

SCHARP provides statistical support and data management to researchers worldwide in the fight against HIV/AIDS with active studies in the U.S., Africa, Latin America, Asia and Europe. SCHARP is responsible for all aspects of data collection, reporting, and statistical analysis for clinical trials following the principles of Good Clinical Practices and Good Clinical Data Management Practices.

Our staff work closely with Fred Hutch scientific faculty to guide research protocol teams on clinical trials methodology and the statistical components of study design, analysis of study data and design of data collection instruments. 

VISION

To improve global human health and eliminate suffering and mortality caused by HIV / AIDS and other diseases.

Mission

To provide high quality data capture, data management and statistical expertise in planning, coordinating, and analyzing clinical research trials worldwide.

Jenny Tseng, RN, reviews clinical trial data.

Photo by Bo Jungmayer / Fred Hutch News Service

SCHARP also develops and maintains the study databases, provides centralized data management, as well as data management training and support for clinical research sites. SCHARP capabilities enable us to handle clinical and lab data from multiple sources, sites and research partners across Hutch's Vaccine and Infectious Disease Division and Biostatistics, Bioinformatics and Epidemiology Program.

With its research partners SCHARP works on new and innovative HIV/AIDS prevention strategies, treatments and vaccines. We are the Statistical and Data Management Center (SDMC) for multiple HIV research networks, including the U.S. National Institute of Allergy and Infectious Diseases' Division of AIDS funded HIV Prevention Trials Network (HPTN), and the HIV Vaccine Trials Network (HVTN), the world’s largest publicly funded international collaboration facilitating the development of HIV/AIDS vaccines, as well as the Bill and Melinda Gates Foundation funded, Collaboration for AIDS Vaccine Discovery (CAVD) , and Vaccine Immunology Statistical Center (VISC).

Statement of Values

Quality — we are committed to continuously improving the quality and scientific excellence of our work.

Ethical Conduct — we strive to maintain the highest ethical standards and scientific integrity.

Respect and Community — we respect the contributions of staff, customers, partners, and study participants and are strengthened by the diversity that each brings.

Organizational Health — we believe in a collaborative work environment that is mission focused, accountable, rewarding, and supportive with empowered and engaged staff.
 

Scharp activities include:

  • Providing statistical and study design expertise
  • Case report forms (CRFs) and e-CRF developmentCDISC CDASH/SDTM compliant databases
  • Conducting study-specific data management training
  • Providing site support for study management and data transfers
  • Web-based electronic data capture (EDC) systems
  • Paper based centralized data entry and quality control support
  • Lab and PRO and CRF data integration
  • Laboratory Data Management System reports
  • Study data maintenance, distribution, warehousing and archiving data
  • Safety data cleaning and clinical review
  • Adverse event coding
  • Study progress monitoring and reporting
  • Independent safety and data monitoring
  • Committee reporting
  • Final study reports production
  • Centralized statistical analysis for presentations and publications