Clinical Protocol and Data Management

临床方案和数据管理

基本信息

批准号：
10406959
负责人：
Charalambos Andreadis
金额：
$ 87.19万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
1999
资助国家：
美国
起止时间：
1999-08-05 至 2023-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10406959
关键词：
Address California Cancer Burden Cancer Center Support Grant Catchment Area Certification Child Clinical Cancer Center Clinical Data Clinical Protocols Clinical Research Clinical Trials Communities Community Outreach Consent County Data Development Ensure Ethics Evaluation Exclusion Guidelines Human Subject Research Individual Infrastructure Institution Institutional Review Boards Investigation Leadership Minority Mission Monitor Nature Oncology Pediatric Oncologist Phase Policies Population Characteristics Population Heterogeneity Procedures Process Protocols documentation Reporting Research Research Activity Research Infrastructure Research Personnel Research Project Grants Research Support Risk Safety Services Standardization System Training United States National Institutes of Health Woman cancer clinical trial cancer health disparity community engagement data management expectation health equity innovation member recruit research study risk benefit ratio systematic review

项目摘要

Clinical Protocol and Data Management: Summary/Abstract This section includes descriptions of the HDFCCC Clinical Protocol and Data Management (CPDM) functions and Data and Safety Monitoring (DSM) functions. CPDM functions are provided by the Clinical Research Support Office (CRSO), and DSM is provided by the Data and Safety Monitoring Committee (DSMC). The development, review, implementation, conduct, monitoring, and reporting of all cancer clinical trials undertaken in the HDFCCC are managed as centralized functions, requiring the coordination of CRSO and DSMC activities with Protocol Review and Monitoring System (PRMS) activities. This coordination is enhanced by the organization of the clinical research infrastructure, in which the activities of the PRMS, DSMC, and the CRSO remain independent but are coordinated by the Cancer Center Clinical Research Oversight Committee (CCCROC; see Director's Overview and Leadership, Planning and Evaluation for full description).

临床协议和数据管理：摘要/摘要本节包括HDFCCC临床协议和数据管理（CPDM）功能的描述以及数据和安全监控（DSM）功能。 CPDM功能由临床研究提供支持办公室（CRSO）和DSM由数据和安全监测委员会（DSMC）提供。这进行的所有癌症临床试验的开发，审查，实施，进行，监测和报告在HDFCCC中，将其作为集中功能管理，需要CRSO和DSMC的协调协议审查和监视系统（PRMS）活动的活动。这种协调通过临床研究基础设施的组织，其中PRM，DSMC和CRSO的活动保持独立，但由癌症中心临床研究监督委员会协调（CCCROC；有关完整描述，请参见导演的概述和领导，计划和评估）。