Autoimmune Diseases Statistical and Clinical Coordinating Center (AD-SCCC)
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AI Contract Overview
The National Institute of Allergy and Infectious Diseases (NIAID) intends to establish the Autoimmune Diseases Statistical and Clinical Coordinating Center (AD-SCCC) to support and advance clinical research in autoimmune diseases, mucosal immunology, and primary immune deficiencies. The center will be responsible for a range of activities including clinical study development, regulatory compliance support for both domestic and international requirements, site monitoring, management of repositories, manuscript production, study archiving, and providing biostatistical expertise. Additionally, the AD-SCCC will collaborate with the DAIT Clinical Data and Safety Management Center (CDSMC) and may offer support for other clinical trials and networks within the NIAID's broader mission on an as-needed basis. This initiative is forecasted under the authority granted by Sections 301 and 405 of the Public Health Service Act and relevant federal regulations. The contract is managed by the National Institutes of Health within the Department of Health and Human Services, with Dr. Jeffrey Rice serving as the primary point of contact. The center's efforts will play a critical role in coordinating and enhancing the execution and analysis of complex clinical trials, thereby facilitating the NIAID’s ongoing research objectives related to autoimmune disorders and related immunological conditions.
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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.
