NIAID Division of Allergy, Immunology and Transplantation: Clinical Site Monitoring Center

This initiative will provide DAIT with comprehensive clinical site monitoring services to fulfill its responsibilities as the funder and/or sponsor of clinical research studies conducted by the immune tolerance network(ITN) by ensuring compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312, Human Subjects Protection Title 45 CFR Part 46, and E6 International Conference on Harmonization good Clinical Practices (ICH/GCP).  In addition, Clinical Site monitoring services will include DAIT-supported, investigator-initiated clinical research studies conducted under grants, as well as other DAIT-funded clinical research programs on a limited, as-needed basis.  These services will be provided for single-and multicenter sites in the U.S. and international sites, including sites in the Americas, the United Kingdom, Western Europe, and Australia.  Types of studies: Phase I - IV; epidemiological; mechanistic; natural history/observational.  Diseases under evaluation: immune mediated, diverse and complex (asthma and allergic diseases; autoimmune disorders; and immune-mediated rejection in solid organ, tissue and cell transplantation).