Biostatistics and Data Management Core

生物统计和数据管理核心

• 批准号: 8260369
• 负责人: PHILIP WILLIAM LAVORI
• 金额: $ 41.48万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2013-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8260369
• 关键词: Area; Biometry; Biostatistics Core; Bone Marrow Transplantation; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Computer Systems; Computers; Consultations; Data; Data Analyses; Data Collection; Data Quality; Data Reporting; Data Storage and Retrieval; Development; Development Plans; Human Resources; Information Systems; International; Journals; Methods; Mission; Modification; Monitor; Multicenter Trials; Patients; Procedures; Process; Production; Program Research Project Grants; Publications; Randomized; Reporting; Research Personnel; Resources; Services; Statistical Study; System; Systems Development; Training; Work; data management; design; experience; investigator training; leukemia/lymphoma; meetings

The Biostatistics Core serves as the resource for biostatistical and data management services for the Program Project Grant in Bone Marrow Transplantation (BMT). These resources can be grouped into the following areas of responsibility: 1) Biostatistical consultation including: planning of new studies, with regard to design, estimation of study size requirements, methods for randomization (where appropriate) and plans for statistical analysis; monitoring of current studies, statistical analysis and scientific reporting of study results; 2) Management of the dedicated computer, including computer systems for data storage and access, development of systems improvements, computer space management, computer administration, trouble shooting, collaboration in report development and collaboration in training of investigators, data managers and other personnel; 3) Coordinating data collection and management for current studies and development of plans for data collection for new studies, including forms design and modification where needed, procedures for entering and tracking patients, randomization of treatment assignments and aid in accessing data for monitoring studies in process and reporting of study results, reporting of data to the Data and Safety Monitoring Board at regular intervals; 4) Procedures for assuring quality of the data collected and production of management reports for administrative and scientific administration, patient accrual, patient status, quality of the data, work progress in tracking patients and special reports requested by investigators; 5) Data management and biostatistical aid in assembling, summarizing and analyzing data for the Data and Safety Monitoring Board, scientific reports for seminars, national and international meetings and for publication in scientific journals. The Biostatistical Core has an established and experienced team in place. Computer and data systems have been developed and are operational for fulfilling the missions described above. The team is composed of a Core Leader, a Core co-leader, Biostatistician, Systems Manager and a Clinical Trials Coordinator who supervises five Clinical Research Assistants one Administrative Assistant.

生物统计核心作为生物统计和数据管理服务的资源 骨髓移植 (BMT) 计划项目拨款。这些资源可以分为 以下职责范围： 1) 生物统计咨询，包括：新研究的规划、设计、研究评估 规模要求、随机化方法（如适用）和统计分析计划； 监测当前研究、统计分析和研究结果的科学报告； 2）专用计算机的管理，包括数据存储和访问的计算机系统， 系统改进开发、计算机空间管理、计算机管理、故障 拍摄、报告编写方面的合作以及调查人员、数据管理人员培训方面的合作 及其他人员； 3）协调当前研究的数据收集和管理以及数据计划的制定 新研究的收集，包括表格设计和需要时的修改、输入程序 跟踪患者、治疗分配的随机化以及帮助获取监测数据 正在进行的研究和研究结果报告，向数据和安全监测报告数据 定期登机； 4) 确保收集的数据质量和管理报告制作的程序 行政和科学管理、患者应计情况、患者状况、数据质量、工作 追踪患者的进展以及研究人员要求的特别报告； 5) 数据管理和生物统计帮助收集、总结和分析数据 和安全监测委员会，为研讨会、国家和国际会议以及 在科学期刊上发表。 生物统计核心拥有一支成熟且经验丰富的团队。计算机和数据系统 已开发并可用于完成上述任务。团队组成 由核心领导者、核心联合领导者、生物统计学家、系统经理和临床试验协调员组成， 监督五名临床研究助理和一名行政助理。