Data & Safety Monitoring

数据

• 批准号: 7714249
• 负责人: Judith D. Goldberg
• 金额: $ 3.01万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-18 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7714249
• 关键词: Adverse event; Amendment; Biostatistics Shared Resource; Characteristics; Clinical; Clinical Investigator; Clinical Trials; Closure; Conflict of Interest; Data; Doctor of Medicine; Dose; Dose-Limiting; Dropout; Eligibility Determination; Enrollment; Ensure; Gynecologic Oncology Group; Health Insurance Portability and Accountability Act; Individual; Institutes; Institution; Investigation; Laboratories; Malignant Neoplasms; Methodology; Monitor; Oncologist; Outcome; Patients; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Principal Investigator; Procedures; Process; Protocol Compliance; Protocols documentation; Rate; Recommendation; Recruitment Activity; Regulation; Reporting; Research Design; Research Personnel; Resolution; Review Committee; Role; Safety; Serious Adverse Event; Severities; Site; Standards of Weights and Measures; Summary Reports; Time; Toxic effect; Validation; base; data management; design; member; oncology

Data Safety Monitoring Committee (DSMC) of the NYU Cancer Institute operates based on the 2001 NCI approved Charter. The DSMC reports to the NYU Cancer Institute Clinical Cancer Investigation Committee (W. Carroll, M.D. Chair; Deputy Director of NYUCI). The DSMC is responsible for monitoring safety, conduct and compliance with protocol data monitoring plans for clinical trials in the Cancer Institute that are not monitored by any other institution or agency, and review of all internal serious adverse events on clinical trials in the Cancer Institute. The scope of this internal DSMC review includes Phase I, Phase II, and Phase I/II studies that are: ¿ NYU Investigator - Initiated protocols ¿ NCI Protocols-not reviewed by NCI ¿ NY GOG - NYU coordinating site The DSMC is composed of clinical investigators/oncologists who are members of the NYUCI, and biostatisticians from the Biostatistics Shared Resource (BSR) who are experts in clinical trial methodology and conduct. The DSMC is supported by staff from the BSR and Clinical Trials Office (CTO). Table 1 lists the members of the DSMC and the staff. The membership of the DSMC is designed to ensure that should there be a conflict of interest for the Chair because of her role on a specific clinical trial, then the Deputy Chair takes over. The same is true for the Oncology members. Additional ad hoc members are also recruited as needed. The DSMC meets monthly to review ongoing clinical trials. This monthly review includes monitoring of three aspects of the protocol: study conduct, safety, and compliance with the data safety monitoring plan. Monitoring for study conduct includes review of: accrual rates, eligibility, compliance, protocol violations, and dropouts. Monitoring for safety includes review of: adverse events (AEs), treatment related AEs, serious adverse events (SAEs), and, for phase I studies, dose limiting toxicities (DLTs). For Phase II studies, compliance with the protocol defined stopping rules is also reviewed along with the results of planned interim analyses. All reviews are based on data provided to the Committee by the Principal Investigator and the CTO. Verification of accuracy of data is conducted by the Internal Audit Committee and editing and validation procedures implemented as part of the data management processes and procedures.

基于2001 NCI的NYU癌症研究所运营的数据安全监测委员会（DSMC） 批准的宪章。 DSMC向纽约大学癌症研究所临床癌症调查委员会报告 （W. Carroll，医学博士主席； Nyuci副主任）。 DSMC负责监视安全性，行为 并遵守癌症研究所临床试验的协议数据监控计划 受任何其他机构或代理机构的监视，并在临床试验中审查所有内部严重不良事件 在癌症研究所。 此内部DSMC综述的范围包括I期，II期和I/II期研究： �NYU研究员 - 启动协议 �NCI协议不由NCI审查 �NYGOG-纽约大学协调网站 DSMC由Nyuci成员的临床研究者/肿瘤学家组成， 来自生物统计学共享资源（BSR）的生物统计学家是临床试验方法和 执行。 DSMC得到了BSR和临床试验办公室（CTO）的工作人员的支持。表1列出了 DSMC和工作人员的成员。 DSMC的成员资格旨在确保主席有利益冲突 由于她在特定的临床试验中的角色，因此副主席接管了。对于 肿瘤学成员。还需要根据需要招募其他临时成员。 DSMC每月开会 审查正在进行的临床试验。本月审查包括监视协议的三个方面：研究 行为，安全和遵守数据安全监控计划。研究行为的监控包括 审查：应计税率，资格，合规性，协议违规和辍学。监视安全性 包括：广告事件（AES），与治疗相关的AE，严重的广告事件（SAE）以及阶段的评论。 我研究，限制剂量策略（DLTS）。对于第二阶段研究，遵守协议定义的停止 还审查了规则以及计划的临时分析结果。所有评论均基于数据 由首席调查员和CTO提供给委员会。数据准确性的验证是 由内部审计委员会以及实施的编辑和验证程序作为一部分 数据管理过程和程序。