IPP: AUTOIMMUNE DISEASES STATISTICAL AND CLINICAL COORDINATING CENTER (ADSCCC)

该合同为自身免疫性疾病和与粘膜免疫学和原发性免疫缺陷相关的疾病的临床研究的设计、开发、执行和分析提供广泛的统计和临床支持。支持的临床研究包括：(i)所有阶段的临床试验，以评估研究产品的安全性和有效性以及用于疾病治疗和预防的创新方法；（ii）作为临床试验组成部分的潜在机制研究；（iii）临床研究（如基因研究、微生物组研究、当前疗法调查等）；（iv）替代物/生物标志物研究。执行的功能包括统计设计和分析；协议的发展;研究发起与管理；临床安全和药物警戒支持；安全监督;临床研究协作门户的管理；样品库的准备和管理。

Contract supports a broad range of statistical and clinical support for the design, development, execution, and analysis of clinical research in autoimmune diseases and diseases related to mucosal immunology and primary immune deficiencies. Clinical research to be supported includes: (i) clinical trials at all phases to evaluate the safety and efficacy of investigational products and innovative approaches for disease treatment and prevention; (ii) studies of underlying mechanisms as integral components of clinical trials; (iii) clinical studies (e.g., genetic studies, microbiome studies, surveys of current therapies, etc.); and (iv) surrogate/biomarker studies. Functions to be performed include statistical design and analysis; protocol development; study initiation and management; clinical safety and pharmacovigilance support; safety oversight; management of clinical study collaboration portals; manuscript preparation and management of sample repositories.