ECOG Statistical Office Data Management Grant

ECOG 统计办公室数据管理补助金

• 批准号: 7931199
• 负责人: ROBERT J GRAY
• 金额: $ 68.99万
• 依托单位: FRONTIER SCI & TECHNOLOGY RSCH FDN, INC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7931199
• 关键词: Adverse event; Area; Award; Chemistry; Clinical; Clinical Trials; Common Data Element; Communication; Computers; Data; Data Collection; Data Quality; Data Storage and Retrieval; Databases; Development; Documentation; Eastern Cooperative Oncology Group; Education; Environment; Expectancy; Future; Grant; Guidelines; Health Insurance Portability and Accountability Act; Hematology; Image; Information Systems; Institution; Investigation; Laboratories; Laboratory Study; Leadership; Maintenance; Management Information Systems; Methodology; Monitor; Office of Administrative Management; Online Systems; Operative Surgical Procedures; Outcome; Paper; Patients; Policies; Privacy; Procedures; Process; Production; Publishing; Quality Control; Randomized; Reporting; Request for Applications; Research; Research Personnel; Route; Sampling; Secure; Solid Neoplasm; Standardization; Statistical Computing; Support System; System; Terminology; Toxic effect; Training; Training Activity; Training and Education; administrative database; computerized; computerized data processing; data management; design; development policy; follow-up; improved; member; migration; patient safety; programs; response; statistical center; tool; web site

DESCRIPTION (provided by applicant): This application requests six years of support for the ECOG Statistical Center. It is a combined narrative for the separate awards for the Statistical Office and the Data Management Office. The objectives of the Statistical Center are to provide leadership and support for ECOG in the areas of design and analysis of clinical and laboratory studies, database analyses and investigator initiated grants, study monitoring, data management procedures and systems, processing and quality control of data, education and training activities, administrative management, and information systems. During this period, ECOG statisticians have continued their strong tradition of leadership in the design and analysis of clinical trials. The statisticians have been coauthors on 143 published ECOG papers, have performed numerous database analyses, and are now providing support for approximately 10 investigator-initiated grants per year. Some of the major accomplishments in data management during the last 5 years include changes in data management procedures to improve efficiency and standardization, including increasing use of computerized processing, improved documentation of procedures, and changes in the routing of data on intergroup studies, active participation in the NCI's Common Data Elements project to standardize data terminology, development of standardized procedures and computer applications for processing data for the new solid tumor response criteria, establishing and implementing guidelines for follow-up durations on ECOG studies and terminating follow-up on many old studies, and development of policies to facilitate compliance with the HIPAA privacy rule by ECOG's member institutions. The efforts to develop better computer applications for data management within the old Ingres database environment eventually led to the realization that it was not an adequate platform on which to build for the future. After investigation of various options, ECOG decided to convert its data management operation to Oracle Clinical. Significant progress on the conversion has been made, with the first study going into production in Oracle in early May. With over 30 years of data from hundreds of studies, and hundreds of applications and reports that access the ECOG database and administrative tables stored in Ingres, the process of data migration and application conversion will continue for several years. This will be the dominant development activity in both data management and in the Information Systems (IS) group for the early part of the next grant period. The IS group has developed a number of important new applications during the last grant period, including enhancements to the ECOG web site, new tools for processing expedited adverse event systems, new follow-up expectancy reporting tools, database procedures for automatic grading of hematology/chemistry related toxicities, tools for processing response data, enhanced support for fiscal management and reimbursement, and new regulatory support systems. The SAS programmers have developed a suite of macros to support data retrieval, reporting and analysis and for performing a variety of data quality control checks. Future Information Systems plans include implementation of improved document management systems, secure communications systems, and document imaging systems for on-line availability of forms and other documents.

描述（由申请人提供）：本申请要求为ECOG统计中心提供六年的支持。这是统计局和数据管理局分别获奖的合并说明。统计中心的目标是在临床和实验室研究的设计和分析、数据库分析和研究者发起的赠款、研究监查、数据管理程序和系统、数据处理和质量控制、教育和培训活动、行政管理和信息系统等领域为ECOG提供领导和支持。 在此期间，ECOG统计学家继续保持其在临床试验设计和分析方面的强大领导传统。这些统计学家是143篇已发表的ECOG论文的合著者，进行了大量的数据库分析，现在每年为大约10个由卫生部发起的赠款提供支持。 在过去5年中，数据管理方面的一些主要成就包括：改变数据管理程序，以提高效率和标准化，包括增加使用计算机处理，改进程序文件，改变组间研究数据的路由，积极参与NCI的通用数据元素项目，以标准化数据术语，开发标准化程序和计算机应用程序，用于处理新实体瘤缓解标准的数据，建立和实施ECOG研究随访持续时间指南，并终止许多旧研究的随访，并制定政策，以促进ECOG成员机构遵守HIPAA隐私规则。在旧的Ingres数据库环境中开发更好的计算机应用程序进行数据管理的努力最终使人们认识到，这不是一个为未来发展所依赖的适当平台。在对各种选项进行调查后，ECOG决定将其数据管理操作转换为Oracle Clinical。转换工作取得了重大进展，第一项研究于5月初在甲骨文公司投入生产。30多年来，数据来自数百项研究，数百个应用程序和报告访问存储在Ingres中的ECOG数据库和管理表，数据迁移和应用程序转换的过程将持续数年。这将是下一个赠款期早期数据管理和信息系统（IS）组的主要开发活动。 IS小组在上一个资助期内开发了许多重要的新应用程序，包括增强ECOG网站、用于处理加速不良事件系统的新工具、新的随访预期报告工具、用于血液学/化学相关毒性自动分级的数据库程序、用于处理应答数据的工具、增强对财务管理和报销的支持以及新的监管支持系统。SAS程序员开发了一套宏指令，以支持数据检索、报告和分析，并执行各种数据质量控制检查。未来的信息系统计划包括实施改进的文件管理系统、安全通信系统和文件成像系统，以便在线提供表格和其他文件。