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。这是统计办公室和数据管理办公室各自奖项的综合叙述。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拨款、研究监测、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。