CORE--Biometry and Data Management

生物测量和数据管理提供支持。它包括生物识别、数据管理和 对参与者进行长期随访。这些组件协作非常紧密，人员 定期相互交流，定期互动。目标是为CCPPP提供生物统计和计算支持，包括生物统计设计和所有临床和实验室研究的审查、样本量计算、统计的发展和维护 数据库，以及研究进展和结果报告。数据管理和长期后续行动的目标是与项目调查人员和工作人员合作，在研究干预期之后为参与者提供数据管理和后续行动。其职责包括设计和开发调查问卷、数据录入和数据库维护、为调查员分析制作数据文件、记录数据收集和数据管理、为数据安全和监测生成不良事件报告、完成病历摘要和表格，以及为终止干预或完成试验的人进行参与者跟踪。生物计量和数据管理对CCPPP的项目至关重要，因为它提供研究设计和数据分析，协助编制表格/问卷，以及在干预之外对参与者进行全面数据管理和后续行动。此外，生物测量和数据管理提供运营和监管报告、提供用于分析的完整记录的数据文件、提供用于与样本匹配的数据、收集肿瘤切片和块、研究设计和数据分析。因此，生物识别和数据管理是 CCPPP。

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.