Administration and Clinical Trial Coordination

管理和临床试验协调

• 批准号: 8476449
• 负责人: Robert S Negrin
• 金额: $ 25.87万
• 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 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8476449
• 关键词: Animals; Area; Autologous Transplantation; Bone Marrow Transplantation; California; Cancer Center; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Communication; Conduct Clinical Trials; Consent Forms; Critiques; Data; Education; Enrollment; Ensure; Extramural Activities; Federal Government; Gender; Grant; Homologous Transplantation; Human Resources; Institutional Review Boards; Instruction; Lead; Leadership; Minority; Outcome; Participant; Patients; Play; Program Research Project Grants; Protocols documentation; Reporting; Research; Research Personnel; Research Project Grants; Research Proposals; Review Committee; Role; Severe Adverse Event; Translations; Transplantation; United States National Institutes of Health; University Hospitals; Visit; Writing; data integrity; follow-up; graft vs host disease; human subject; leukemia/lymphoma; meetings; member; operation; programs; protocol development

The Administration and Clinical Trial Coordination Core A will serve as the central organizational hub of the Program. This Core will have 5 main functions: 1) To coordinate the administrative and fiscal management of the Program Project; 2) To provide research coordination and review through meetings of internal program members and external consultants; 3) To provide support for all of the clinical trials by providing consistency in IRB interactions, severe adverse event reporting, clinical grading of graft vs host disease and regulatory expertise; 4) To coordinate follow-up of patients who have undergone transplantation on clinical trials of this PPG; 5) To ensure access of both genders and all minorities to clinical trials. The Core will provide oversight and fiscal management to the Project and coordinate these efforts through dedicated personnel with expertise in these defined areas. Since many of the clinical trials require FDA oversight through INDs central coordination of this effort through organization of the INDs, communication with the FDA and reporting of outcomes to institutional and external regulatory bodies will be a critical role for the Core. Centralizing this effort will provide expertise and consistency in these efforts. The Core will organize and facilitate a panel of external consultants who will visit the Program yearly and provide critique and guidance. A monthly Program Project meeting will also be organized by the Core. The Core leader will liaison with Divisional, Departmental and Cancer Center personnel to enhance interactions and facilitate discoveries. All of the Projects and Cores will utilize Core A functions.

管理和临床试验协调核心 A 将作为该计划的中央组织中心。该核心将具有 5 个主要功能： 1）协调计划项目的行政和财务管理； 2) 通过内部项目成员和外部顾问会议提供研究协调和审查； 3) 通过提供IRB相互作用、严重不良事件报告、移植物抗宿主病临床分级和监管专业知识的一致性，为所有临床试验提供支持； 4) 协调本PPG临床试验中接受移植患者的随访； 5) 确保男女和所有少数群体都能参加临床试验。 核心部门将为该项目提供监督和财务管理，并通过在这些特定领域具有专业知识的专职人员协调这些工作。由于许多临床试验需要 FDA 通过 IND 进行监督，通过 IND 的组织来集中协调这项工作，因此与 FDA 的沟通以及向机构和外部监管机构报告结果将是 核心。集中这项工作将为这些工作提供专业知识和一致性。核心将组织和促进一个外部顾问小组，他们每年都会访问该计划并提供批评和指导。核心还将组织每月一次的计划项目会议。核心领导将与部门、部门和癌症中心人员联络，以加强互动并促进 发现。所有项目和核心都将利用核心 A 功能。