STATISTICAL SUPPORT UNIT

统计支持单位

• 批准号: 7515853
• 负责人: CHARLES L LOPRINZI
• 金额: $ 92.1万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-14 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7515853
• 关键词: Address; Adverse event; Biostatistics Shared Resource; Books; Cancer Control; Case Report Form; Clinic; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Common Data Element; Data; Data Collection; Databases; Development; Doctor of Philosophy; Electronics; Factor Analysis; Generations; Goals; Human Resources; Individual; Information Systems; Information Technology; Leadership; Maintenance; Malignant Neoplasms; Manuals; Mayo Clinic Cancer Center; Monitor; North Central Cancer Treatment Group; Online Systems; Operative Surgical Procedures; Pathology; Patients; Protocols documentation; Quality Control; Randomized; Records; Reporting; Resource Sharing; Role; Sample Size; Scheme; Serious Adverse Event; Specialist; Specific qualifier value; Stratification Factors; Subgroup; System; Training; Translational Research; concept; data management; design; instrument; member; programs; statistics

2.6.3.3 NCCTG Statistical Data Center The NCCTG Statistical Data Center (SDC), under the direction of the Group Statistician, Daniel J. Sargent, Ph.D., is comprised of two units: the Statistics Unit and the Data Systems Unit. The two units function in a highly coordinated fashion under the leadership of Dr. Sargent and the Group Operations Coordinator. Together, these two units provide statistical collaboration, data management support, and information technology (IT) support for the development and conduct of NCCTG cancer clinical trials, including translational research. The Statistics Unit exists within the Mayo Clinic Cancer Center (MCCC) Biostatistics Shared Resource, also directed by Dr. Sargent, where statistical support for multiple programs provides synergies that benefit all. There are over 40 individuals currently in this shared resource. The NCCTG Statistics Unit currently consists of portions of 8 Ph.D statisticians, 9 master trained statisticians, 10 statistical programmer analysts (SPAs).and 2 administrative assistants. The Data Systems Unit, under the direction of Ms. Paulson, exists within the MCCC Clinical Research Office Shared Resource that includes over 140 individuals. Again, the high degree of interaction provides synergies that benefit all. The NCCTG Data Systems Unit is comprised of three subgroups: 1. Programming Unit with 17 Analyst/Programmers. 2. Data Coordination Unit with 4 Data Management Specialists and 1 Administrative Assistant. 3. Clinical Trials Coordination that includes the Quality Control Unit, the Randomization Unit, and the Compliance Unit. The Quality Control Unit includes 18 Quality Control Specialists,'the NCCTG SAE Coordinator, the NCCTG Pathology Coordinator, the NCCTG Surgery Coordinator, and 1 supervisor. The Randomization Unit includes 3 Randomization Specialists. The Compliance Unit includes 2 Compliance Specialists. While the personnel within the Compliance Unit are considered members of the Data Systems Unit, their activities are defined by the NCCTG Audit Committee.

2.6.3.3 NCCTG统计数据中心 NCCTG 统计数据中心 (SDC) 在集团统计师 Daniel J. Sargent 的指导下， 博士，由两个单位组成：统计单位和数据系统单位。这两个单元在一个 在萨金特博士和集团运营协调员的领导下高度协调的时尚。 这两个单位共同提供统计协作、数据管理支持和信息 为 NCCTG 癌症临床试验的开发和实施提供技术 (IT) 支持，包括 转化研究。 统计部门位于 Mayo Clinic 癌症中心 (MCCC) 生物统计共享资源内，也 由萨金特博士指导，对多个项目的统计支持提供了惠及所有人的协同效应。 目前该共享资源中有超过 40 人。 NCCTG 统计部门目前包括 8 名统计学博士、9 名硕士培训统计学家、10 名统计程序员分析师 (SPA) 的部分人员。 行政助理2名。 MCCC 临床研究办公室内设有数据系统部门，由 Paulson 女士领导 包括超过 140 人的共享资源。再次强调，高度互动带来协同效应 这对所有人都有好处。 NCCTG 数据系统部门由三个小组组成： 1. 具有 17 名分析员/程序员的编程单元。 2. 数据协调组，配备 4 名数据管理专家和 1 名行政助理。 3. 临床试验协调，包括质量控制单位、随机分组单位和 合规单位。质量控制部门包括 18 名质量控制专家，'NCCTG SAE 协调员、NCCTG 病理学协调员、NCCTG 手术协调员和 1 名主管。 随机化小组包括 3 名随机化专家。合规部门包括 2 合规专家。虽然合规部门的人员被视为 数据系统部门，其活动由 NCCTG 审计委员会定义。