Core--Clinical Trials, Data Management and Statistics

核心--临床试验、数据管理和统计

• 批准号: 6892954
• 负责人: ANNETINE A GELIJNS
• 金额: $ 100.64万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-01-01 至 2009-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6892954
• 关键词: automated medical record system; auxiliary heart prosthesis; biomedical facility; cardiovascular disorder therapy; clinical trials; congestive heart failure; data collection methodology /evaluation; data management; experimental designs; medical implant science; medical outreach /case finding; statistical service /center; statistics /biometry; therapy design /development

The Clinical Trials, Data Management, and Statistics (CTDMS) Core will provide the clinical coordination and data management for all patient-based experiments in the SCCOR, as well as the data management for all non-clinical experiments. This core will also provide the statistical expertise to interpret the data. The Core is comprised of three functional units: clinical coordination; data management; and statistics. These functions will be performed by the International Center for Health Outcomes and Innovation Research (InCHOIR), a university based clinical and data coordinating center that is a collaborative effort of the Mailman School of Public Health and the College of Physicians and Surgeons of Columbia University, New York. The CTDMS will provide several critical functions in the SCCOR studies: (1) Protocol Development. The Core investigators will be involved in the finalization of the protocols for all clinical studies and in the development of electronic Case Report Forms (eCRFs) and Operations Manuals. (2) Clinical Coordination. The Core will be in regular contact with the clinical centers to review patient enrollment, discuss recruitment strategies to ensure optimal enrollment of women and minority patients, assist the clinical investigators in drafting management guidelines, and review the management of SCCOR patients. (3) Data Management. The Core will provide a secure, validated, centralized electronic data management facility that is HIPAA and FDA-compliant. The Core will develop and maintain systems to enable direct data entry via the Web, provide automated patient randomization, time stamping, file archiving, data validation and reporting services, and a telephone help desk for technical support. (4) Site Management, Quality Assurance, and Monitoring. The Coordinating Core will train the clinical investigators in the specifics of the protocol, review the quality of the data, issue queries, monitor the sites on a regular basis to ensure data quality and integrity, and assist the Morbidity and Mortality Committee in adjudicating the data. (5) Statistical and Analytical Support. The Core will provide statistical design and analytical support to the final planning of the experiments, generate the randomized treatment assignments, perform the interim analyses for the Data Safety and Monitoring Board (DSMB), perform the final analyses, and participate in the preparation of study presentations and manuscripts.

临床试验、数据管理和统计（CTDMS）核心将提供临床 SCCOR中所有基于患者的实验的协调和数据管理，以及所有非临床实验的数据管理。这一核心还将提供解释数据的统计专门知识。该核心由三个职能单位组成：临床协调、数据管理和统计。这些职能将由国际健康成果和创新研究中心（InCHOIR）执行，该中心是一个基于大学的临床和数据协调中心，由梅尔曼公共卫生学院和纽约哥伦比亚大学内科医生和外科医生学院共同努力。CTDMS将在SCCOR研究中提供几项关键功能：（1）方案制定。核心研究者将参与所有临床研究方案的定稿以及电子病例报告表（eCRF）和操作手册的开发。(2)临床协调。核心将定期与临床中心联系，以审查患者入组，讨论招募策略以确保女性和少数民族患者的最佳入组，协助临床研究者起草管理指南，并审查SCCOR患者的管理。(3)数据管理功能内核会提供一个安全的 符合HIPAA和FDA标准的经验证的集中式电子数据管理设施。核心小组将开发和维护各种系统，以便能够通过网络直接输入数据，提供自动化的患者随机化、时间戳、文件存档、数据验证和报告服务，以及提供技术支持的电话服务台。(4)研究中心管理、质量保证和监测。协调核心将对临床研究者进行方案细节方面的培训，审查数据质量，发出质询，定期监测研究中心以确保数据质量和完整性，并协助死亡率和死亡率委员会裁定数据。(5)统计和分析支持。核心人员将为实验的最终计划提供统计设计和分析支持，生成随机化治疗分配，为数据安全性和监查委员会（DSMB）进行中期分析，进行最终分析，并参与研究报告和手稿的编写。