数据和安全监控委员会-猫眼课题宝

数据和安全监控委员会

批准号：

8010918

负责人：

SVEN DE VOS

金额：

$16.43万

依托单位：

UNIVERSITY OF CALIFORNIA LOS ANGELES

依托单位国家：

美国

项目类别：

财政年份：

资助国家：

美国

项目状态：

未结题

起止时间：

至

来源：

https://reporter.nih.gov/project-details/8010918

关键词：

Address Adverse event Affect Amendment Businesses Case Study Clinical Data Update System Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Communication Comprehensive Cancer Center Consensus Data Doctor of Philosophy Drops Educational Activities Employee Enrollment Ensure Frequencies Funding Human Industry Interview Knowledge Leadership Michigan Minnesota Mission Monitor Monitoring Clinical Trials Online Systems Patient Rights Peer Review Pennsylvania Persons Phase Positioning Attribute Principal Investigator Process Protocol Compliance Protocols documentation Recommendation Recruitment Activity Reporting Research Research Design Research Ethics Committees Review Committee Risk Safety Self-Examination Serious Adverse Event Services Social Welfare Students Study Subject System Testing Time Universities Voting Right Work anticancer research authority base database structure design follow-up meetings member programs quality assurance reconstitution response safety study

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英文摘要

Data Safety Monitoring Board In response to the NCI mandate, the JCCC Data and Safety Monitoring Board (DSMB) was constituted in January, 2001, and has been meeting weekly since then. Our complete DSMB plan was submitted to the NCI on 9/18/01 and approved 3/8/2002. The JCCC DSMB oversees the implementation of the data monitoring plans approved by the Protocol Review and Monitoring System/Institutional Scientific Review Committee (PRMS/ISPRC) and on file with the JCCC. The JCCC DSMB and PRMS/ISPRC have been significantly reorganized over the past 3 years and there is little overlap between the 2 committees. The administrative aspects of the DSMB are coordinated through the same office as the PRMS/ISPRC which allows for more effective communication and coordination. Partial funding for staff that supports the JCCC DSMB is requested in this application.

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