Core A: Administration and Clinical Trial Coordination Core

核心 A：管理和临床试验协调核心

• 批准号: 10475731
• 负责人: Robert S Negrin
• 金额: $ 24.78万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-05-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10475731
• 关键词: Animals; Area; Autologous Transplantation; Awareness; Biometry; Bone Marrow Transplantation; California; Cell Therapy; Cells; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Communication; Conduct Clinical Trials; Consent; Consent Forms; Critiques; Data; Data Collection; Education; Enrollment; Ensure; Extramural Activities; Federal Government; Gender; Homologous Transplantation; Institutes; Institutional Review Boards; Laboratories; Leadership; Malignant Neoplasms; Minority; Monitor; Patients; Process; Production; Program Research Project Grants; Protocols documentation; Reporting; Research; Research Personnel; Research Project Grants; Research Proposals; Resources; Review Committee; Running; Series; Serious Adverse Event; Services; Standardization; United States National Institutes of Health; Universities; University Hospitals; Visit; Woman; Work; Writing; clinical translation; data integrity; data management; follow-up; human subject; international center; leukemia/lymphoma; meetings; minority patient; novel; operation; participant enrollment; programs; protocol development

Core A (Administration and Clinical Trial Coordination Core): Project Summary/Abstract Core A will serve as the administrative hub for the entire Program Project Grant. Core A will be responsible for all fiscal matters related to the Program and will interact with all of the Project and Core Leaders, administrative officials at Stanford University as well as NIH Officers to ensure smooth and thorough oversight of research and clinical operations, fiscal and regulatory matters. Core A will organize and run a monthly Program Project meeting where each Project and Cores B and C will be presented to the group once to twice yearly. Core A will also organize a yearly day long External Consultants Visit where each Project and Core will be presented in depth to our external advisors for their critique and review. A written summary will be provided and distributed to appropriate investigators. Core A will also be responsible for coordinating the proposed clinical trials by standardizing interactions with the Stanford University IRB, FDA where indicated, Stanford Cancer Institute and NIH Officials. Core A will be responsible for developing order sets for the clinical aspects of the studies, consenting eligible patients, reporting severe adverse events to appropriate regulatory bodies and supporting data management with Core B. Core A will also work with the Stanford Cancer Institute to enhance awareness and enrollment of eligible women and minority patients to the clinical trials described in this application. Core A will monitor scientific and clinical progress of the Projects and when needed coordinate necessary changes and revisions as well as ensure availability of Core B and C resources to all of the Projects utilizing those services. In summary, Core A is integral to the organization, coordination and implementation of this PPG.

核心A(管理和临床试验协调核心)：项目摘要/摘要 核心A将作为整个计划项目赠款的行政中心。核心A将负责 所有与计划有关的财务事项，并将与所有项目和核心领导、行政部门 斯坦福大学的官员以及NIH的官员，以确保对研究和 临床运营、财政和监管事务。核心A将组织并主持每月一次的计划项目会议 其中每个项目和核心B和C将每年向小组提交一至两次。核心A也将 每年组织为期一天的外部顾问访问，在那里将深入介绍每个项目和核心 我们的外部顾问对他们的批评和审查。将提供书面摘要并分发给 适当的调查人员。核心A还将负责协调拟议的临床试验，方法是 标准化与斯坦福大学IRB、FDA、斯坦福癌症研究所和 美国国立卫生研究院的官员。核心A将负责为研究的临床方面开发顺序集， 同意符合条件的患者，向适当的监管机构报告严重不良事件并提供支持 与核心B进行数据管理。核心A还将与斯坦福癌症研究所合作，提高人们的认识 并招募符合条件的妇女和少数族裔患者参加本申请中描述的临床试验。核心A 将监测项目的科学和临床进展，并在必要时协调必要的变化和 并确保向利用这些服务的所有项目提供核心B和C资源。 总而言之，核心A是组织、协调和执行这一项目小组不可或缺的一部分。