经济组统计办公室-猫眼课题宝

经济组统计办公室

批准号：

7276141

负责人：

ROBERT J GRAY

金额：

$236.71万

依托单位：

DANA-FARBER CANCER INST

依托单位国家：

美国

项目类别：

财政年份：

1978

资助国家：

美国

项目状态：

已结题

起止时间：

1978-03-01 至 2010-04-30

来源：

https://reporter.nih.gov/project-details/7276141

关键词：

AML/MDS Access to Information Accounting Activation Date Acute Acute Promyelocytic Leukemia Address Adjuvant Adjuvant Study Administrator Adopted Adoption Adult Adverse Drug Experience Reporting System Adverse effects Adverse event Affect African American Agreement Algorithms All Sites Amendment American College of Radiology American Society of Clinical Oncology American Society of Hematology Antigens Application procedure Area Authorization documentation Award Back Basic Science Bayesian Analysis Bibliography Bioinformatics Biological Markers Biometry Bite Blinded Blood Books Brain Brain Neoplasms Breast Budgets Business Rules Businesses CD-ROM Cancer Center Cancer Control Cancer Patient Cancer Survivor Cancer Therapy Evaluation Program Cancer Trials Support Unit Cancer and Leukemia Group B Carboxyamidotriazole Case Report Form Case Study Categories Caucasians Caucasoid Race Charge Chemistry Chest Cisplatin Class Classification Clinic Clinical Clinical Data Clinical Data Update System Clinical Investigator Clinical Protocols Clinical Research Clinical Research Associate Clinical Trials Clinical Trials Cooperative Group Clinical Trials Data Monitoring Committees Clinical Trials Design Clinics and Hospitals Closure Code Coin Collection Colon Carcinoma Commit Committee Members Common Data Element Common Terminology Criteria for Adverse Events Communication Communities Community Clinical Oncology Program Complex Complication Computer Security Computer Systems Computer Systems Development Computer software Computers Concept Review Conduct Clinical Trials Confidence Intervals Confidentiality Conflict of Interest Congresses Consent Consent Forms Contractor Contracts Controlled Clinical Trials Controlled Study Copyright Correlative Study Count Critiques Cross-Over Studies Custom Cytotoxic agent Daily Dana-Farber Cancer Institute Data Data Analyses Data Base Management Data Collection Data Coordinating Center Data Element Data Files Data Quality Data Reporting Data Set Data Storage and Retrieval Database Management Systems Databases Date of birth Date/Time Decision Making Derivation procedure Development Development Plans Devices Diabetes Mellitus Diagnostic Imaging Dictionary Digit structure Discipline Disease Disorder by Site Doctor of Philosophy Documentation Dose Dose-Limiting Drug Formulations Eastern Cooperative Oncology Group Education Educational Status Educational workshop Effectiveness Elderly Electronic Mail Electronics Elements Eligibility Determination Employee End Point Enrollment Ensure Environment Equilibrium Equipment and supply inventories Ethnic Origin Ethnic group Evaluation Evaluation Studies Event Exercise stress test Expectancy Experimental Designs Extensible Markup Language Factor Analysis Faculty Failure FarGo Feasibility Studies Feedback Floor Focus Groups Follow-Up Studies Foundations Freezing Funding Future GDF15 gene Gender Generations Genus - Lotus Goals Grant Gray unit of radiation dose Group Meetings Group Processes Group Purchasing Guidelines Hand Head Head and Neck Cancer Head and neck structure Health Insurance Portability and Accountability Act Health behavior Healthcare Hematology Hodgkin Disease Hormonal Hospital Records Hospitals Hour Housing Human Human Resources Human Subject Research Image Impact evaluation Incidence Individual Industry Information Services Information Systems Information Technology Informed Consent Institutes Institution Intention Intercept Interferon-alpha International Internet Intervention Investigation Journals Label Laboratories Laboratory Scientists Laboratory Study Language Latex Lead Leadership Learning Left Letters Librarians Libraries Licensing Life Lilium Link Literature Local Area Networks Location Logic Lymphoma Mails Maintenance Malignant Neoplasms Malignant neoplasm of gastrointestinal tract Malignant neoplasm of kidney Malignant neoplasm of lung Management Information Systems Manuals Manuscripts Maps Marketing Massachusetts Measurement Measures Mediation Medical Records Melissa Mentors Metastatic Melanoma Methodology Methods Minority Mission Modality Modeling Modification Monitor Motivation Multi-Institutional Clinical Trial Multiple Myeloma Names National Cancer Institute Natural regeneration Nature New Agents Nodal Non-Small-Cell Lung Carcinoma Nonprofit Organizations Normal Range North Central Cancer Treatment Group Notification Numbers Nurses Object Attachment Office of Administrative Management Oncologic Nursing Oncology Nurse One-Step dentin bonding system Online Systems Operative Surgical Procedures Outcome Output PLAB Protein Paper Parents Participant Pathologist Pathology Pathology Report Patient Noncompliance Patient Selection Patients Pattern Peer Review Performance Pharmaceutical Preparations Pharmacologic Substance Phase Phase I Clinical Trials Phase II Clinical Trials Phase III Clinical Trials Physicians Pilot Projects Planet Mars Plant Roots Play Pliability Plug-in Policies Policy Developments Population Positioning Attribute Pre-study Preparation Prevention Price Principal Investigator Printing Privacy Probability Procedures Process Production Prognostic Factor Progress Reports Progression-Free Survivals Prohibit Protocol Compliance Protocols documentation Public Health Schools Publications Published Comment Publishing Purpose Quality Control Quality of life Race Radiation Oncology Radiation Therapy Oncology Group Radiation therapy Randomized Randomized Controlled Clinical Trials Range Rate Reaction Reading Recommendation Recording of previous events Records Recurrence Relative (related person)Reliance Renal Cell Carcinoma Renal carcinoma Reporting Request for Applications Research Research Design Research Ethics Committees Research Infrastructure Research Personnel Reservations Resolution Resources Retrieval Risk Risk Factors Role Route Running Ruta SAS Safety Sample Size Sampling Scanning Schedule Science Scientist Score Screening procedure Second Primary Cancers Secure Security Series Serious Adverse Event Services Side Significance Level Site Site Visit Social Security Number Software Validation Solid Solid Neoplasm Solutions Source Southwest Oncology Group Specialist Specific qualifier value Specimen Speed Spottings Stable Disease Staff Development Staging Standard Preparations Standardization Standards of Weights and Measures Statistical Computing Statistical Methods Statistical Study Stratification Stratification Factors Structure Study Section Subgroup Supervision Support System Survival Rate Suspension substance Suspensions System Target Populations Technical Expertise Technology Telefacsimile Telephone Terminology Testing Text Therapeutic Therapeutic Clinical Trial Therapeutic Studies Thesauri Thinking Thoracic Oncology Tigers Time Time Study Tissue Banks Tissue Sample Tissues Title To specify Toxic effect Toxicity due to chemotherapy Training Training Activity Training Programs Training and Education Translating Transplantation Travel Treatment Protocols Treatment Step Tretinoin Uncontrolled Study United States Food and Drug Administration Universities Update Upper arm Urogenital Cancer Valid Value Validation Vendor Virus Visit Voting Waiting Lists Walking Week Weight Woman Work Workload Writing abstracting adjudicate administrative database anticancer research base cancer therapy chemotherapy clinical application commercial application computer generated computerized computerized data processing concept cost cost effective dalton data integrity data management database design day demographics design development policy digital disorder prevention efficacy evaluation encryption expectation experience falls file format firewall follow-up frontier hazard human subject improved indexing innovation instrument interest lecturer lectures leukemia leukemia/lymphoma malignant breast neoplasm medical schools melanoma member microwave electromagnetic radiation migration new technology optical character recognition outcome forecast patient safety payment pressure prevent probation prognostic programs protocol development quality assurance racial and ethnic response sarcoma simulation size skills software development software systems statistical center statistics success symposium symptom management syntax technical report theories time use tool tool development trafficking transmission process treatment duration treatment effect treatment trial tumor upper GI series validation studies web based interface web interface

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中文摘要

翻译

说明(申请人提供)：本申请请求为经社理事会统计中心提供六年的支持。这是对统计处和数据管理处不同奖项的综合说明。统计中心的目标是在临床和实验室研究的设计和分析、数据库分析和调查员发起的赠款、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经社理事会提供领导和支持。在此期间，ECOG统计学家延续了他们在临床试验设计和分析方面的强大领导传统。统计人员与他人共同撰写了143篇发表的经社理事会论文，进行了大量的数据库分析，现在每年为大约10名研究人员发起的赠款提供支助。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，包括更多地使用计算机化处理，改进程序记录，改变小组间研究的数据传递方式，积极参与NCI的公共数据元素项目以标准化数据术语，为处理新的实体肿瘤反应标准的数据开发标准化程序和计算机应用程序，建立和实施针对ECOG研究后续持续时间的准则，并终止对许多旧研究的后续行动，以及制定政策以促进ECOG成员机构遵守HIPAA隐私规则。为在旧的Ingres数据库环境内开发更好的数据管理计算机应用程序所作的努力，最终导致人们认识到，这不是一个为未来建设的适当平台。在研究了各种选择后，ECOG决定将其数据管理业务转换为Oracle Clinic。在转换方面取得了重大进展，第一项研究于5月初在甲骨文投入生产。借助来自数百项研究的30多年数据，以及访问经社理事会数据库和存储在Ingres中的管理表的数百个应用程序和报告，数据迁移和应用程序转换的进程将持续数年。在下一个赠款期间初期，这将是数据管理和信息系统小组的主要发展活动。在上一次赠款期间，IS小组开发了一些重要的新应用程序，包括对ECOG网站的改进、用于处理快速不良事件系统的新工具、新的后续预期报告工具、用于血液学/化学相关毒性自动分级的数据库程序、用于处理反应数据的工具、加强对财政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，以支持数据检索、报告和分析，并用于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。

英文摘要

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.

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