ECOG Statistical Office Data Management Grant

ECOG 统计办公室数据管理补助金

• 批准号: 7472519
• 负责人: ROBERT J GRAY
• 金额: $ 246.13万
• 依托单位: FRONTIER SCI & TECHNOLOGY RSCH FDN, INC
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-08-05 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7472519
• 关键词: Adverse event; Area; Award; Chemistry; Clinical; Clinical Trials; Common Data Element; Communication; Computers; Data; Data Collection; 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; Internet; Investigation; Laboratories; Laboratory Study; Leadership; Maintenance; Management Information Systems; Methodology; Monitor; Numbers; Office of Administrative Management; Online Systems; Operative Surgical Procedures; Outcome; Paper; Patients; Policies; Policy Developments; Privacy; Procedures; Process; Production; Publishing; Quality Control; Randomized; Reporting; Request for Applications; Research; Research Personnel; Route; SAS; Sampling; Secure; Site; 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

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）：本申请要求对ECOG统计中心的六年支持。这是统计办公室和数据管理办公室单独奖项的组合叙述。统计中心的目标旨在在临床和实验室研究，数据库分析和研究人员的设计和分析领域为ECOG提供领导力和支持，从而启动了赠款，研究监测，数据管理程序和系统，对数据，教育和培训活动，行政管理以及信息系统的处理和质量控制。 在此期间，ECOG统计学家在临床试验的设计和分析中延续了他们的牢固领导传统。统计学家曾是143份已发表的ECOG论文的合着者，进行了许多数据库分析，现在为每年大约10个调查员发起的赠款提供支持。 在过去5年中，数据管理方面的某些主要成就包括数据管理程序的变化，以提高效率和标准化，包括增加使用计算机化处理的使用，改进的程序文档，以及组中研究数据路由的变化，积极参与NCI的NCI公共数据元素，以便为标准化数据和计算机的数据进行响应，以使标准化的数据和计算机数据的实现，并为标准化的数据进行了努力，并开发了标准化的数据，并将其开发为标准化的数据，并将其用于处理标准化的数据ECOG研究的后续持续时间和终止了许多旧研究的后续行动，以及制定政策以促进ECOG的成员机构遵守HIPAA隐私规则。在旧的INGRES数据库环境中为数据管理开发更好的计算机应用程序的努力最终使人们意识到这不是一个适合未来的足够平台。经过各种选择，ECOG决定将其数据管理操作转换为Oracle临床。转换已经取得了重大进展，首次研究于5月初在Oracle进行生产。有来自数百项研究的30多年数据，以及数百种访问ECOG数据库和存储在Ingres的管理表的应用程序和报告，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的数据管理和信息系统（IS）组中的主要开发活动。 IS集团在上一个赠款期内开发了许多重要的新应用程序，包括增强ECOG网站的功能，处理加快不良事件系统的新工具，新的后续预期报告工具，用于自动血液学/化学相关毒性分级的数据库程序，用于处理的工具，处理响应的工具，加工响应数据，增强对货币管理的支持和新的支持系统和新的支持系统。 SAS程序员已经开发了一套宏来支持数据检索，报告和分析，并为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档管理系统，安全通信系统以及文档成像系统，以在线可用形式和其他文档。