NIAID CLINICAL DATA AND SAFETY MANAGEMENT CENTER (CDSMC)

通过合同授予，过敏，免疫学和移植部门打算提供临床数据和安全管理中心（CDSMC），以支持NIAID资助的临床试验和免疫介导疾病的临床研究的广泛临床研究数据管理，安全性和药物警戒管理。承包商将建立一个CDSMC，为NIAID支持的国内和/或国际研究的临床试验和研究（包括机制）提供数据管理和报告、临床安全性和药物警戒以及样本跟踪流程。支持的主要科学领域包括过敏性疾病和哮喘;自身免疫性疾病;实体器官、组织和细胞移植中的免疫介导的排斥反应;原发性免疫缺陷疾病;以及其他免疫系统疾病和增强免疫功能的治疗，但可能扩展到NIAID赞助的其他领域。

Through the contract award, the Division of Allergy, Immunology, and Transplantation intends to provide a Clinical Data and Safety Management Center (CDSMC) to support a wide range of clinical research data management, safety and pharmacovigilance management for NIAID-funded clinical trials and clinical studies of immune-mediated diseases. The Contractor will establish a CDSMC that will provide Data Management and Reporting, Clinical Safety and Pharmacovigilance, and a Specimen Tracking processes for NIAID supported clinical trials and studies (including mechanistic) for both domestic and/or international research. Primary scientific areas of support include allergic diseases and asthma; autoimmune disorders; immune-mediated rejection in solid organ, tissue and cell transplantation; primary immune deficiency disorders; and other immune system disorders and treatments to enhance immune functions but may expand to other NIAID sponsored areas