REDS-IV-P DATA COORDINATING CENTER PHASE 2

受者流行病学和捐献者评估研究-IV-儿科(REDS-IV-P)计划的目标是评估和改善血液供应的安全性和可用性，以及输血治疗的安全性和有效性，不仅关注成年人，也关注需要输血的新生儿和儿童。REDS-IV-P是一项为期七年的多中心计划，在美国和巴西，负责在献血者和输血接受者中进行流行病学和实验室研究。REDS-IV-P计划由4个国内枢纽和一个巴西输血计划组成，涉及来自美国和巴西血液中心的研究人员。每个国内枢纽都有一个血液中心和输血服务，为参加REDS-IV-P的几家专科护理和社区医院(总共22家医院)提供服务。国内枢纽和巴西国际项目都得到了数据协调中心(DCC)和输血实验室研究中心(CTLS)的支持。REDS-IV-P分为3个阶段：1)第1阶段(第1-2年)包括制定REDS-IV-P研究方案，开发和试点相关联的捐献成分-接受者(静脉对静脉)数据库，进行第1阶段研究，并利用现有的输血数据库进行数据分析；2)第2阶段(第3-5年)包括进行第2阶段研究方案，汇编静脉-静脉数据库和数据分析，以及通过介绍和出版物传播研究结果；3)第三阶段(第6-7年)包括通过陈述和出版物传播调查结果，关闭数据库，并向NHLBI提供所有交付成果。本合同是DCC第二阶段活动的合同。

The objectives of the Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) program is to evaluate and improve the safety and availability of the blood supply, as well as the safety and effectiveness of transfusion therapies, with attention to not only adults, but also neonates and children who need transfusion. REDS-IV-P is a seven-year multicenter program, in the US and in Brazil, charged with conducting epidemiologic and laboratory studies in blood donors and transfusion recipients. The REDS-IV-P Program is comprised of 4 domestic hubs and a Brazil transfusion program involving investigators from the U.S. and from the Brazilian blood centers. Each domestic hub has a blood center and transfusion services that serve several specialty care and community hospitals participating in REDS-IV-P (total of 22 hospitals). The domestic Hubs and the Brazil international programs are each supported by a Data Coordinating Center (DCC) and Center for Transfusion Laboratory Studies (CTLS). REDS-IV-P is divided into 3 phases: 1) Phase 1 (Years 1-2) includes development of the REDS-IV-P research protocols, the development and pilot of a linked donation-component-recipient (vein to vein) database, the conduct of phase 1 research studies, and the conduct of data analyses using existing transfusion databases; 2) Phase 2 (Years 3-5) includes the conduct of phase 2 research protocols, compilation of the vein to vein database and data analyses, and dissemination of findings through presentations and publications; and 3) Phase 3 (Years 6-7) includes dissemination of findings through presentations and publications, closure of databases, and provision of all deliverables to NHLBI. This contract is for the DCC phase 2 activities.