DATA AND SAFETY MONITORING

数据和安全监控

• 批准号: 8436456
• 负责人: William L. Carroll
• 金额: $ 2.85万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-03-01 至 2018-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8436456
• 关键词: Adverse event; Cancer Center Support Grant; Clinical Investigator; Clinical Trials; Conduct Clinical Trials; Data; Data Collection; Enrollment; Ensure; Institutes; Institution; Institutional Review Boards; Instruction; Kaplan Cancer Center; Malignant Neoplasms; Monitor; Multicenter Trials; Phase; Pilot Projects; Policies; Procedures; Protocols documentation; Regulation; Reporting; Research; Research Methodology; Research Personnel; Resources; Review Committee; Safety; Serious Adverse Event; Site; base; data integrity; medical schools; multidisciplinary; patient safety; quality assurance

PROJECT SUMMARY (See Instructions): The Data and Safety Monitoring Committee (DSMC) of the NYU Cancer Institute (NYUCI) operates based on the Data and Safety Monitoring Plan approved by the NCI in November 2011 and the highest priority is placed on ensuring the safety of patients who enroll on clinical trials. The DSMC is a multidisciplinary committee composed of clinical investigators, biostatisticians and research administrative staff from the Clinical Trials Office (CTO), all with expertise in research methodology and the conduct of clinical trials. The DSMC reports to the Director of the NYUCI (WilHam L. Carroll, MD). The DSMC oversees the conduct of institutional trials. In addition, the NYUCI Internal Audit Committee and Phase I/II Committee review all Investigator-Initiated trials or Multi-Center Trials which NYUCI is the coordinating center. The lAC is a quality assurance mechanism to assess compliance with protocol procedures and data integrity, FDA regulations and CTO policy. Phase I/II Committee provides a mechanism to more closely monitor accrual, timeliness of data collections, adverse events and the available resources needed to achieve study endpoints.

项目总结（见说明）： 纽约大学癌症研究所（NYUCI）的数据和安全性监测委员会（DSMC）根据NCI于2011年11月批准的数据和安全性监测计划开展工作，最优先考虑的是确保入组临床试验的患者的安全性。DSMC是一个多学科委员会，由临床试验办公室（CTO）的临床研究者、生物统计学家和研究管理人员组成，他们都具有研究方法和临床试验实施方面的专业知识。DSMC向NYUCI主任（WilHam L.医学博士卡罗尔）。DSMC监督机构试验的进行。此外，NYUCI内部审计委员会和I/II期委员会审查所有研究者发起的试验或NYUCI作为协调中心的多中心试验。lAC是一种质量保证机制，用于评估方案程序和数据完整性、FDA法规和CTO政策的合规性。I/II期委员会提供了一种机制，以更密切地监测应计、数据收集的及时性、不良事件和实现研究终点所需的可用资源。