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: 10700020
• 负责人: Robert S Negrin
• 金额: $ 25.28万
• 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/10700020
• 关键词: Animal Experiments; 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; Eligibility Determination; Enrollment; Ensure; Extramural Activities; Federal Government; Gender; Homologous Transplantation; Human; Institution; 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 communication; 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）：项目总结/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 与项目相关的所有财务事项，并与所有项目和核心领导人、行政管理人员 斯坦福大学的官员以及NIH官员，以确保研究的顺利和彻底的监督， 临床操作、财政和监管事宜。核心A将组织并召开每月一次的计划项目会议 每个项目以及核心B和C将每年向小组提交一至两次。核心A还将 每年组织一次为期一天的外部顾问访问，深入介绍每个项目和核心， 我们的外部顾问的批评和审查。将提供书面摘要并分发给 合适的调查员。核心A还将负责协调拟定的临床试验， 标准化与斯坦福大学IRB、FDA（如适用）、斯坦福大学癌症研究所的互动， NIH官员。核心A将负责开发研究临床方面的订单集， 知情同意合格患者，向适当监管机构报告严重不良事件，并支持 核心B的数据管理。核心A还将与斯坦福大学癌症研究所合作，提高认识 以及本申请中描述的临床试验中合格的妇女和少数民族患者的招募。芯A 将监测项目的科学和临床进展，并在需要时协调必要的变更， 修订，并确保核心B和C资源可用于使用这些服务的所有项目。 100.总之，核心A是本项目规划补助金的组织、协调和执行的一个组成部分。