WOMEN'S HEALTH INITIATIVE - CLINICAL COORDINATING CENTER

妇女健康倡议 - 临床协调中心

• 批准号: 9463728
• 负责人: GARNET ANDERSON
• 金额: $ 1052.79万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9463728
• 关键词: Biological; Clinical; Contractor; Data Analyses; Development; Documentation; Government; Laboratories; Lead; Maintenance; Manuals; Monitor; Morbidity - disease rate; Observational Study; Performance Status; Procedures; Quality Control; Security; Specimen; System; Training; Women' s Health; adjudication; data management; meetings; mortality; protocol development; technical report

The Clinical Coordinating Center contractor will continue to perform data management and analysis activities including the documentation and maintenance of appropriate confidentiality and security of files for the study and sub-studies; lead the development of the protocol and manuals of procedures development; continue to support a morbidity/mortality monitoring and adjudication system; maintain quality control and monitoring of the performance status of the Regional Centers; maintain the biological specimen laboratory; solicit and monitor laboratories; coordinate, arrange, participate in, and provide any information necessary for regular Steering Committee, Observations Study Monitoring Board, training and other necessary study meetings; and provide technical reports as required by the Government.

临床协调中心承包商将继续执行数据管理和分析活动，包括记录和维护研究和子研究文件的适当机密性和安全性；领导程序开发方案和手册的制定；继续支持发病率/死亡率监测和裁决系统；维持区域中心绩效状态的质量控制和监控；维护生物样本实验室；征求和监督实验室；协调、安排、参与并提供定期指导委员会、观察研究监测委员会、培训和其他必要的研究会议所需的任何信息；并按政府要求提供技术报告。