Autoimmune Diseases Statistical and Clinical Coordinating Center (AD-SCCC)
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The National Institute of Allergy and Infectious Diseases within the National Institutes of Health is seeking to establish an Autoimmune Diseases Statistical and Clinical Coordinating Center to support clinical trials focused on autoimmune diseases, mucosal immunology, and primary immune deficiencies. The selected entity will be responsible for clinical study development, biostatistical support, repository management, manuscript production, study archiving, and ensuring compliance with domestic and international regulatory requirements and site monitoring. This initiative involves collaboration with the Division of Allergy, Immunology and Transplantation Clinical Data and Safety Management Center and may extend to other networks within the NIAID mission on an emergent basis. The opportunity is categorized as a forecast under NAICS code 541715 and is authorized under the Public Health Service Act and applicable Federal Regulations.
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Full Description
The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance its mission by establishing an Autoimmune Diseases Statistical & Clinical Coordinating Center (AD-SCCC). The AD-SCCC will provide clinical study development, support domestic and international regulatory requirements, site monitoring, repository management, manuscript production, study archiving, and biostatistical support for ongoing and future clinical trials in the areas of autoimmune diseases, mucosal immunology, and primary immune deficiencies. Additional tasks include collaboration with the Division of Allergy, Immunology and Transplantation (DAIT) Clinical Data and Safety Management Center (CDSMC) and may include support on an emergent basis for other networks and clinical trials within the NIAID mission. Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
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