The BLOODSAFE Data Coordinating Center: A Data Center for More SafeTransfusions in Sub-Saharan Africa

BLOODSAFE 数据协调中心：撒哈拉以南非洲地区更安全输血的数据中心

• 批准号: 10197218
• 负责人: Cavan S. Reilly
• 金额: $ 98.34万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10197218
• 关键词: Acute; Africa; Africa South of the Sahara; Anemia; Biometry; Blood; Blood Transfusion; Child; Clinical Research; Clinical Trials; Collaborations; Communities; Conflict (Psychology); Data; Data Analyses; Data Collection; Data Coordinating Center; Data Element; Democratic Republic of the Congo; Development; Device or Instrument Development; Discipline of obstetrics; Ebola; Ebola Hemorrhagic Fever; Ebola virus; Ensure; Epidemic; Fire - disasters; Goals; Hemorrhage; Improve Access; Information Dissemination; Infrastructure; International; Investigation; Laboratories; Leadership; Liberia; Liberian; Logistics; Malaria; Medicine; Minnesota; National Heart, Lung, and Blood Institute; Observational Study; Outcome; Participant; Pathology; Policies; Principal Investigator; Randomized; Randomized Controlled Trials; Reporting; Research; Research Design; Research Personnel; Resistance; Science; Scientist; Sickle Cell Anemia; Specimen; System; Therapeutic; Time; Training; Transfusion; Translating; United States; Universities; Vulnerable Populations; Woman; Work; World Health Organization; blood product; clinical investigation; clinical research site; data centers; data harmonization; data management; data quality; data standards; design; experience; genome wide association study; implementation intervention; improved; multidisciplinary; novel; programs; protocol development; public health emergency; quality assurance; research study; response; training opportunity

Project Summary The goal of this project is to provide biostatistical leadership and data management infrastructure for the BLOODSAFE initiative, an NHLBI initiative which seeks to increase the supply of safe blood available for transfusion in Sub-Saharan Africa. This leadership includes coordination of activities across multiple projects, collaboration with scientists at NHLBI on program oversight and provision of expertise regarding all aspects of study design and implementation. This expertise includes but is not limited to coordination with local experts, provision of training to local experts, assistance with study design, harmonization of data elements across multiple studies, assistance with implementation of interventions, data management, data quality assurance, data analysis and study finding dissemination to ensure that discoveries are communicated to the scientific community and translated into local best practices in a timely manner. These goals will be fulfilled by completion of the following aims: provide study coordination activities and oversight across all studies at all stages of study development, including regulatory oversight, logistical support and training opportunities in conjunction with NHLBI; provide expertise in study design, initiation and implementation; provide expertise in data management including standardization of data elements, design of data collection instruments, development of data quality assurance systems and systems for specimen tracking; and provide expertise in all aspects of study reporting, data analysis and result dissemination and development of novel analysis strategies as required for fulfilment of study objectives.

项目摘要 该项目的目标是为生物统计学提供领导和数据管理基础设施， BLOODSAFE倡议，一项NHLBI倡议，旨在增加安全血液的供应， 在撒哈拉以南非洲的输血。这种领导包括协调多个项目的活动， 与NHLBI的科学家合作，对项目进行监督，并提供有关项目各个方面的专业知识。 研究设计和实施。这种专门知识包括但不限于与当地专家协调， 为当地专家提供培训，协助研究设计，协调各机构的数据要素， 多项研究，协助实施干预措施，数据管理，数据质量保证， 数据分析和研究结果传播，以确保将发现传达给科学家， 并及时转化为当地最佳做法。这些目标将通过以下方式实现： 完成以下目标：提供研究协调活动并监督所有研究 研究开发阶段，包括监管监督、后勤支持和培训机会 与NHLBI合作;提供研究设计、启动和实施方面的专业知识;提供以下方面的专业知识 数据管理，包括数据要素的标准化，数据收集工具的设计， 开发数据质量保证系统和样本跟踪系统;并提供以下方面的专业知识 研究报告、数据分析、结果传播和新分析开发的所有方面 实现研究目标所需的策略。