NIAID CLINICAL DATA AND SAFETY MANAGEMENT CENTER (CDSMC)

NIAID 临床数据和安全管理中心 (CDSMC)

• 批准号: 10493771
• 负责人: DANIEL MOLINA
• 金额: $ 781.9万
• 依托单位: TECHNICAL RESOURCES INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2022-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10493771
• 关键词: Allergic Disease; Area; Autoimmune Diseases; Award; Cell Transplantation; Clinical; Clinical Data; Clinical Research; Clinical Trials; Contractor; Contracts; Data Reporting; Disease; Extrinsic asthma; Funding; Hypersensitivity; Immune; Immune System Diseases; Immunologic Deficiency Syndromes; Immunology; International; Mediating; Mission; National Institute of Allergy and Infectious Disease; Organ Transplantation; Process; Research; Safety; Safety Management; Solid; Specimen; Tissue Transplantation; Transplantation; Work; data management; immune function; pharmacovigilance

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

通过该合同，过敏、免疫学和移植部门打算提供一个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、安全性和药物警惕管理。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（包括机械性）提供数据管理和报告、临床安全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、组织和细胞移植中免疫介导的排斥反应原发性免疫缺乏性疾病；以及其他免疫系统疾病和增强免疫功能的治疗方法，但可能会扩展到其他NIAID赞助的领域