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Project

International Clinical Studies Support Center (ICSSC)

PAST PROJECT
Funder
Division of Microbiology and Infectious Diseases of the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases
Duration
2000 - 2019

The International Clinical Studies Support Center (ICSSC) at FHI 360 provides a wide range of support services to clinical investigators conducting international research on treatment, prevention and control of infectious diseases in developing countries. The center’s goal is to enhance the capacity of international clinical sites to perform clinical research in accordance with international standards and to facilitate the planning and conduct of clinical evaluations of interventions against infectious diseases. The ICSSC has served researchers in 50 countries, providing training, consultation and assistance in the following areas:

  • Clinical research
  • Good clinical practices (GCP)
  • Site assessment and site preparedness
  • Protocol development
  • Adverse event (AE) reporting and monitoring
  • Case report form design
  • Statistics and statistical analysis
  • Data management plans, assessments and systems development
  • Manuscript preparation
  • Science writing

The ICSSC’s work includes developing an array of practical international training programs — offered both in-person and online — to help standardize processes across sites and improve quality in data management, biostatistics, ethics, field operations, protocol-specific issues and AE reporting in accordance with all applicable guidelines and regulations. The center has translated GCP training materials into French, Spanish, Portuguese, Mandarin and Vietnamese. In addition, the ICSSC organizes and facilitates seven annual meetings in International Research in Infectious Diseases.

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