Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10022669
• 负责人: Matthew Galsky
• 金额: $ 28.04万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10022669
• 关键词: Adult; African American; Age; Award; Budgets; Cancer Center Support Grant; Cancer Patient; Caring; Catchment Area; Child; Childhood; Clinical; Clinical Data; Clinical Nursing Research; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Communication; Data; Development; Disease; Enrollment; Ensure; Event; Family; Geographic Locations; Geography; Guidelines; Hispanics; Individual; Institutes; Intervention; Lead; Longevity; Malignant Childhood Neoplasm; Malignant Neoplasms; Minority; Mission; Monitor; Monitoring Clinical Trials; Oncologist; Oncology; Participant; Patients; Pediatric Hematology; Pediatric Oncology Group; Phase; Population; Protocols documentation; Reporting; Research; Research Personnel; Safety; Structure; Therapeutic; Therapeutic Clinical Trial; Therapeutic Intervention; Therapeutic Trials; TimeLine; Training; Training and Education; Woman; age group; aged; cancer care; cancer clinical trial; cancer therapy; clinical trial enrollment; data management; evidence base; high risk; human old age (65+); innovation; malignant breast neoplasm; medical schools; member; multidisciplinary; patient population; recruit; repository; safety study; sound

PROJECT SUMMARY/ABSTRACT Part I: Clinical Protocol and Data Management The primary mission of the Clinical Protocol and Data Management team, also referred to as the Cancer Clinical Trials Office (CCTO), is to assist Tisch Cancer Institute investigators in the development, conduct, and reporting of innovative clinical research in an efficient, regulatory-compliant, and scientifically sound manner. The CCTO comprises the following functions: study coordination, data management, regulatory management, pre-award budgeting, training and education. Part II: Data and Safety Monitoring All cancer clinical trials are monitored according to the guidelines set forth in the TCI Data and Safety Monitoring Plan (DSMP) which was previously reviewed and approved by the NCI. A formal Data and Safety Monitoring Committee (DSMC) was established in 2008 to ensure that investigator-initiated clinical trials in the TCI are compliant with the data and safety monitoring plans approved by the PRMC. The DSMC is accountable to and reports to the Associate Director for Clinical Research. Part III: Inclusion of Women and Minorities and Part IV: Inclusion Across the Lifespan TCI successfully recruits significant proportions of minority patients onto clinical trials. The TCI is highly committed to adhering to CCSG principles in providing state-of-the-art evidence-based, family-and-child- oriented, multi-disciplinary cancer treatment for women, minorities, and patients of all ages.

项目概要/摘要 第一部分：临床方案和数据管理 临床方案和数据管理团队（也称为癌症临床）的主要任务 试验办公室 (CCTO)，协助蒂施癌症研究所研究人员进行开发、实施和报告 以高效、合规且科学合理的方式进行创新临床研究。首席技术官 包括以下职能：研究协调、数据管理、监管管理、预奖励 预算、培训和教育。 第二部分：数据和安全监控 所有癌症临床试验均根据 TCI 数据和安全监测中规定的指南进行监测 计划 (DSMP) 此前已由 NCI 审查并批准。正式的数据和安全监控 委员会 (DSMC) 成立于 2008 年，旨在确保 TCI 中研究者发起的临床试验 符合 PRMC 批准的数据和安全监测计划。 DSMC 负责并 向临床研究副主任报告。 第三部分：妇女和少数群体的包容性和第四部分：整个生命周期的包容性 TCI 成功招募了大量少数族裔患者参加临床试验。 TCI 非常高 致力于遵守 CCSG 原则，提供最先进的基于证据的家庭和儿童服务 为女性、少数族裔和所有年龄段的患者提供面向多学科的癌症治疗。