STATISTICAL SUPPORT UNIT

2.6.3.3 NCCTG统计数据中心 NCCTG统计数据中心(SDC)，由集团统计学家丹尼尔·J·萨金特领导， 博士学位由两个单位组成：统计股和数据系统股。这两个单元在一个 在萨金特博士和集团业务协调员的领导下，高度协调。 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 翻译研究。 统计股存在于梅奥诊所癌症中心(MCCC)生物统计共享资源内，还 由萨金特博士指导，其中对多个项目的统计支持提供了协同效应，使所有人都受益。 这个共享资源中目前有40多个人。NCCTG统计股目前由 在8名博士统计员中，9名受过硕士培训的统计员，10名统计程序分析员(SPA)。 2名行政助理。 数据系统股在保尔森女士的领导下，设在MCCC临床研究办公室内 包括140多个人的共享资源。同样，高度的互动提供了协同效应 这对所有人都有利。NCCTG数据系统股由三个小组组成： 1.编程股有17名分析员/编程员。 2.数据协调股，有4名数据管理专家和1名行政助理。 3.临床试验协调，包括质量控制股、随机股和 合规部。质量控制部门包括18名质量控制专家，NCCTG SAE 协调员、NCCTG病理协调员、NCCTG手术协调员和1名主管。 随机股包括3名随机化专家。合规股包括2个 合规专家。虽然合规股内的人员被认为是 数据系统股，其活动由NCCTG审计委员会定义。

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.