DATA AND SAFETY MONITORING

项目总结(见说明)： 纽约大学癌症研究所(NYUCI)的数据和安全监测委员会(DSMC)根据NCI于2011年11月批准的数据和安全监测计划运作，最优先考虑的是确保登记参加临床试验的患者的安全。临床试验管理委员会是一个多学科委员会，由临床试验办公室(CTO)的临床研究人员、生物统计学家和研究行政人员组成，他们都拥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.Carroll，MD)报告。Dsmc监督机构试验的进行。此外，NYUCI内部审计委员会和第一/第二阶段委员会审查所有由调查员发起的试验或以NYUCI为协调中心的多中心试验。Lac是一种质量保证机制，用于评估遵守协议程序和数据完整性、FDA法规和CTO政策的情况。第一阶段/第二阶段委员会提供了一个机制，以便更密切地监测数据收集的应计费用、及时性、不良事件和实现研究终点所需的可用资源。

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.