Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10674517
• 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/10674517
• 关键词: Accountability; Adult; African American; African American population; 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; Dedications; Development; Disease; Event; Family; Geographic Locations; Geography; Guidelines; Hispanic; Hispanic Populations; Individual; Intervention; Lead; Longevity; Malignant Childhood Neoplasm; Malignant Neoplasms; Minority; Minority Groups; Minority Women; 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; 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+); improved; innovation; malignant breast neoplasm; medical schools; member; minority patient; multidisciplinary; participant enrollment; patient population; recruit; repository; safety study; sound; timeline

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.

项目总结/摘要 第I部分：临床方案和数据管理 临床方案和数据管理团队的主要使命，也称为癌症临床 临床试验办公室（CTO）协助Tisch癌症研究所的研究人员开发、实施和报告 以高效、符合法规和科学合理的方式进行创新临床研究。CTO 包括以下功能：研究协调、数据管理、法规管理、预授予 预算编制、培训和教育。 第二部分：数据和安全性监测 所有癌症临床试验均根据TCI数据和安全性监测中规定的指南进行监测。 计划（DSMP），之前已由NCI审查和批准。正式的数据和安全性监测 委员会（DSMC）成立于2008年，以确保在TCI中进行的药物启动的临床试验 符合PRMC批准的数据和安全性监测计划。DSMC负责并 向临床研究副主任报告。 第三部分：妇女和少数群体的融入和第四部分：整个生命周期的融入 TCI成功地招募了相当比例的少数民族患者参加临床试验。TCI是高度 致力于坚持CCSG原则，提供最先进的循证，家庭和儿童- 面向女性、少数民族和所有年龄段患者的多学科癌症治疗。