Clinical Protocol and Data Management/Clinical Trials Office (Core-007)

临床方案和数据管理/临床试验办公室 (Core-007)

• 批准号: 9149630
• 负责人: MARSHALL R POSNER
• 金额: $ 16.5万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9149630
• 关键词: 21 year old; Basic Science; Budgets; Cancer Center Support Grant; Caring; Catchment Area; Child; Childhood; Clinical Data; Clinical Protocols; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Data Monitoring Committees; Complement; Data; Data Reporting; Databases; Development; Ensure; Family; Future; Guidelines; Hispanics; Institutes; Institutional Review Boards; Malignant Childhood Neoplasm; Malignant Neoplasms; Medical; Medical center; Minority; Mission; Monitor; Neighborhoods; Participant; Pediatric Hematology; Pediatric Oncology Group; Phase; Population; Population Sciences; Process; Protocols documentation; Reporting; Research; Research Activity; Research Personnel; Research Support; Risk; Safety; Services; Side; Stem cell transplant; Therapeutic; Training and Education; Update; Woman; abstracting; base; cancer care; cancer clinical trial; cancer site; cancer therapy; cohort; data management; development policy; evidence base; high risk; innovation; member; oncology; programs; quality assurance; safety study; sound; stem cell therapy

ABSTRACT – CLINICAL PROTOCOL AND DATA MANAGEMENT Part I: Clinical Protocol and Data Management The primary mission of the CCTO is to assist the Tisch Cancer Institute Investigators in the development, conduct, and reporting of innovative clinical research in an efficient, compliant and scientifically sound manner. The CCTO is composed of regulatory, financial, clinical, study management, compliance programs, data management and reporting that provide uniformity and consistency in clinical research by supporting investigators. There is a Quality Assurance Program (QAP) responsible for centralized education and training services, subject central registration, auditing, development of policy and supports the TCI Data and Safety Monitoring Committee (DSMC). The CCTO also provides a central location for cancer protocols, a centralized database of protocol-specific data, and an updated list of active protocols. 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). A formal Data and Safety Monitoring Committee (DSMC) was established to ensure that all clinical trials in the TCI have an adequate data and safety monitoring plan commensurate with level of risk. Part III: Inclusion of Women and Minorities The Mount Sinai Medical Center is uniquely juxtaposed between three culturally, ethnically, and economically distinct neighborhoods: the Upper East Side is predominately white, East Harlem predominately Hispanic and Black and Central Harlem predominantly Black and Hispanic. In addition, TCI clinicians provide medical care, and TCI investigators are engaged in ongoing research, for the unique World Trade Center (WTC) cohort. These four components comprise the TCI catchment area and are a principal focus of our clinical, basic and population sciences research initiatives. Part IV: Inclusion of Children in Clinical Research Pediatric cancer care is provided through the Jack Martin Division of Pediatric Hematology-Oncology, where Mount Sinai is a full member of the Children's Oncology Group (COG). A full complement of therapeutic options including allo- and auto- stem cell transplantation are available through the FACT-accredited stem cell therapy program.

摘要 – 临床方案和数据管理 第一部分：临床方案和数据管理 CCTO 的主要任务是协助蒂施癌症研究所研究人员开发、 以高效、合规和科学合理的方式进行和报告创新临床研究。 CCTO 由监管、财务、临床、研究管理、合规计划、数据 管理和报告通过支持提供临床研究的统一性和一致性 有一个质量保证计划（QAP）负责集中教育和培训。 服务、主题中央注册、审计、政策制定并支持 TCI 数据和安全 监测委员会 (DSMC) 还为癌症协议提供了一个中心位置，一个集中的中心。 协议特定数据的数据库以及活动协议的更新列表。 第二部分：数据和安全监控 所有癌症临床试验均根据 TCI 数据和安全性中规定的指南进行监测 成立了正式的数据和安全监控委员会 (DSMC)，以确保监控计划 (DSMP)。 TCI 中的所有临床试验都有与试验水平相称的充分数据和安全监测计划 风险。 第三部分：妇女和少数群体的包容性 西奈山医疗中心独特地融合了三个文化、种族和经济特征 独特的社区：上东区以白人为主，东哈莱姆区以西班牙裔为主， 黑人和哈莱姆区中部主要是黑人和西班牙裔。此外，TCI 长者提供医疗服务， TCI 的研究人员正在针对世界贸易中心 (WTC) 的独特群体进行持续的研究。 这四个部分构成了 TCI 的服务领域，是我们临床、基础和临床研究的主要焦点。 人口科学研究举措。 第四部分：将儿童纳入临床研究 小儿癌症护理由杰克·马丁小儿血液肿瘤科提供，其中 西奈山是儿童肿瘤学组 (COG) 的正式成员。 通过 FACT 认证的干细胞可提供包括同种异体和自体干细胞移植在内的选择 治疗计划。