REDS-IV-P BRAZIL TRANSFUSION SAFETY RESEARCH PROGRAM 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是美国和巴西的一个为期七年的多中心计划，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，美国调查人员和国际血液中心的调查人员参与了该计划。国内枢纽和巴西国际项目由一个数据协调中心(DCC)和一个输血实验室研究中心(CTLS)提供支持。REDS-IV-P巴西输血安全研究计划是一项为期7年的计划，包括三个阶段，每个阶段有以下特定终点：1)阶段1(第1-2年)：制定第2阶段多点研究组合；开展试点研究以建立捐赠者和捐献数据库；开发和实施下一阶段镰状细胞病(SCD)队列研究；并酌情开展第1阶段研究，解决SCD患者和非SCD患者的血液安全和输血研究优先事项，并告知第2阶段研究组合的性质；2)第二阶段(第3-5年)：开展第二阶段多站点研究组合，包括数据库汇编(S)，巴西SCD队列研究的纵向后续行动，以及针对关键的血液安全和输血研究优先事项进行第二阶段研究；和3)第三阶段(第6-7年)：在SCD和非SCD环境中进行第三阶段研究，以酌情解决新的或新出现的研究问题；通过演示文稿和出版物传播研究结果；以及向外部研究界提供资源，如可共享的数据集。本合同是第二阶段巴西方案的基准期。

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 U.S. investigators and investigators at international blood centers. The domestic Hubs and the Brazil international programs are supported by one data coordinating center (DCC) and one center for transfusion laboratory studies (CTLS). The REDS-IV-P Brazil Transfusion Safety Research Program is a 7-year program consisting of three phases, each with the following specific endpoints: 1) Phase 1 (Years 1-2): Development of the Phase 2 multi-site research portfolio; conduct of a pilot study to establish the donor and donation database; development and implementation of the next phase of the sickle cell disease (SCD) cohort study; and, as appropriate, conduct of Phase 1 research studies that address blood safety and transfusion research priorities for patients with SCD as well as in non-SCD settings, and inform the nature of the Phase 2 research portfolio; 2) Phase 2 (Years 3-5): Conduct of the Phase 2 multi-site research portfolio including database(s) compilation, longitudinal follow -up of the Brazil SCD cohort study, and conduct of Phase 2 research studies that address key blood safety and transfusion research priorities; and 3) Phase 3 (Years 6-7): Conduct of Phase 3 research studies in SCD and non-SCD settings to address new or emerging research questions, as appropriate; dissemination of research findings through presentations and publications; and provision of resources such as sharable datasets to the external research community. This contract is for the base period of the Brazil Program for phase 2.