Clinical Protocol and Data Management

临床方案和数据管理：摘要/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).