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; 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），在小组统计学家Daniel J. Sargent的指导下 博士学位由两个单元组成：统计单元和数据系统单元。这两个单元在一个 在萨金特博士和小组运营协调员的领导下，高度协调的时尚。 这两个单元一起提供统计协作，数据管理支持和信息 技术（IT）支持NCCTG癌症临床试验的发展和行为，包括 翻译研究。 统计单元存在于Mayo临床癌症中心（MCCC）生物统计学共享资源中，也存在 由萨金特（Sargent）博士指导，在其中对多个计划的统计支持提供了有益于所有人的协同作用。 目前，此共享资源中有40多个人。 NCCTG统计单元当前组成 在8个博士学位统计学家，9位经过培训的统计学家，10位统计程序员分析师（SPA）和 2个行政助理。 在保尔森女士的指导下，数据系统部门存在于MCCC临床研究办公室内 共享资源，包括140多个人。同样，高度互动提供协同作用 这使一切受益。 NCCTG数据系统单元由三个亚组组成： 1。编程单元，配备17位分析师/程序员。 2。具有4位数据管理专家和1名行政助理的数据协调单位。 3。临床试验协调，包括质量控制单元，随机单元和 合规单位。质量控制单元包括18位质量控制专家，'NCCTG SAE 协调员，NCCTG病理协调员，NCCTG手术协调员和1位主管。 随机单元包括3位随机专家。合规单位包括2个 合规专家。虽然合规部门内的人员被认为 数据系统部门，其活动由NCCTG审计委员会定义。