CORE--Biometry and Data Management

核心——生物测定和数据管理

• 批准号: 7905728
• 负责人: SYLVAN B. GREEN
• 金额: $ 70.48万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7905728
• 关键词: Adverse event; Biometry; Clinical; Colon Carcinoma; Data; Data Analyses; Data Collection; Data Files; Data Reporting; Databases; Development; Documentation; Generations; Goals; Human Resources; Intervention; Laboratory Study; Maintenance; Medical Records; Monitor; Outcome; Participant; Prevention program; Production; Program Research Project Grants; Questionnaires; Reporting; Research Design; Research Personnel; Safety; Sample Size; Slide; cancer prevention; data management; design; follow-up; sample collection; tumor

Biometry and Data Management provides support. It consists of Biometry, Data Management and Participant Long-Term Follow-Up. These components collaborate very closely, and the personnel regularly interact with each other regularly. The objective is to provide biostatistical and computational support to the CCPPP, including biostatistical design and review of all clinical and laboratory studies, sample size calculations, development and maintenance of statistical databases, and study progress and outcome reports. The goals of Data Management and Long-term Follow-up are to collaborate with project investigators and staff in the provision of data management and follow-up of participants beyond the intervention period of the study. The responsibilities include the design and development of questionnaires, data entry and database maintenance, production of data files for investigator analyses, documentation of data collection and data management, generation of adverse event reports for data safety and monitoring, completion of medical record abstraction and forms, and participant follow-up for those who terminate the intervention or complete the trial. The Biometry and Data Management is essential to the projects of the CCPPP, as it provides study design and data analysis, assistance with form/questionnaire development, and overall data management and follow-up of participants beyond the intervention. In addition, Biometry and Data Management provides operational and regulatory reporting, provision of fully documented data files for analysis, provision of data for matching with specimens and collection of tumor slides and blocks, study design, and data analysis. As such, Biometry and Data Management is a critical component of the CCPPP.

生物统计学和数据管理提供支持。它包括生物统计学，数据管理和 参与者长期随访。这些部门密切合作， 经常互相交流。目的是为CCPPP提供生物统计和计算支持，包括所有临床和实验室研究的生物统计设计和审查、样本量计算、统计数据的开发和维护， 数据库、研究进展和结果报告。数据管理和长期随访的目标是与项目研究者和工作人员合作，在研究干预期之后提供数据管理和参与者随访。其职责包括设计和开发调查问卷、数据录入和数据库维护、为研究者分析生成数据文件、记录数据收集和数据管理、为数据安全性和监测生成不良事件报告、完成病历摘要和表格以及对终止干预或完成试验的受试者进行随访。生物统计学和数据管理对CCPPP的项目至关重要，因为它提供研究设计和数据分析，协助表格/问卷编制，以及整体数据管理和干预措施以外的参与者随访。此外，生物统计学和数据管理提供操作和监管报告，提供完整记录的数据文件用于分析，提供与标本匹配的数据，收集肿瘤切片和组织块，研究设计和数据分析。因此，生物统计和数据管理是 CCPPP。