Core--Clinical Trials, Data Management and Statistics

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。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结果和创新研究中心(INCHOIR)执行，这是一个总部设在大学的临床和数据协调中心，是梅尔曼公共卫生学院和纽约哥伦比亚大学内科和外科学院的合作努力。CTDMS将在SCCOR研究中提供几个关键功能：(1)协议制定。核心调查员将参与所有临床研究方案的最后定稿，并参与开发电子病例报告表和操作手册。(2)临床协作。中心将与临床中心保持定期联系，以审查患者登记，讨论招募战略，以确保妇女和少数族裔患者的最佳登记，协助临床调查人员起草管理指南，并审查SCCOR患者的管理。(3)数据管理。核心将提供一个安全、 经过验证的集中式电子数据管理设施，符合HIPAA和FDA标准。该中心将开发和维护系统，以便能够通过网络直接输入数据，提供自动患者随机化、时间戳、文件存档、数据验证和报告服务，以及一个电话技术支持服务台。(4)现场管理、质量保证和监控。协调核心将对临床调查人员进行议定书细节方面的培训，审查数据质量，发出查询，定期监测地点，以确保数据质量和完整性，并协助发病率和死亡率委员会裁决数据。(5)统计和分析支持。该中心将为实验的最终计划提供统计设计和分析支持，生成随机处理任务，为数据安全和监测委员会执行中期分析，执行最终分析，并参与研究报告和手稿的准备工作。

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.