REDS-IV-P BRAZIL TRANSFUSION SAFETY RESEARCH PROGRAM PHASE 2

REDS-IV-P项目的目的是评价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，不仅关注成人，还关注需要输血的新生儿和儿童。REDS-IV-P是美国和巴西的一项为期7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项目由4个国内中心和一个巴西输血项目组成，该项目涉及美国研究人员和国际血液中心的研究人员。 国内中心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巴西输血安全性研究项目是一项为期7年的项目，包括三个阶段，每个阶段具有以下特定终点：1）第1阶段（1-2年级）：开发2期多中心研究组合;开展试点研究，建立捐献者和捐献数据库;开发和实施下一阶段的镰状细胞病（SCD）队列研究;并在适当情况下，开展1期研究，以解决SCD患者以及非SCD患者的血液安全性和输血研究优先事项，并告知2期研究组合的性质; 2）2期（3-5年级）：开展II期多中心研究组合，包括数据库汇编、巴西SCD队列研究的纵向随访，开展2期研究，解决关键的血液安全和输血研究优先事项;以及3）3期（6-7年级）：在SCD和非SCD环境中进行第3阶段研究，以解决新的或正在出现的研究问题;通过演讲和出版物传播研究结果;以及向外部研究界提供可共享的数据集等资源。该合同适用于巴西方案第二阶段的基准期。

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.