Clinical Protocol and Data Management

临床方案和数据管理

• 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
• 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

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).

临床方案和数据管理：摘要/摘要