Administration and Clinical Trials

给药和临床试验

• 批准号: 8556457
• 负责人: Jeffrey S Weber
• 金额: $ 20.7万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-20 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8556457
• 关键词: Administrator; Award; Budgets; Clinical; Clinical Trials; Communication; Data; Development; Ensure; Florida; Goals; Human Resources; Individual; Information Dissemination; Laboratories; Logistics; Patient advocacy; Peer Review; Performance; Process; Progress Reports; Research; Research Personnel; Research Project Grants; Running; Skin; Skin Cancer; anticancer research; career development; data management; meetings; melanoma; member; programs; research and development

The Administrative/Clinical Trials Core C will serve to facilitate communication and manage interactions among SPORE investigators, and between SPORE members and other research and administrative units at Moffitt and with the NCI. Core C will provide organizational and financial oversight of all 4 projects, 3 cores and the Developmental Research and Career Development Programs, as well as provide for clinical trials coordination and data management support for all four melanoma trials integral to the Moffitt Skin SPORE. It includes support for a data manager and a clinical trials coordinator who will be critical to the performance of the trials of the SPORE. Administrative Core C also includes support for an administrator and an assistant who will have overall day to day responsibility for the successful carrying out of all SPORE activities, including financial oversight and coordination, publicity and record keeping, and critically will coordinate the integration of the regulatory and oversight activities in the running of the Moffitt Skin SPORE. This will assure that all administrative requirements for successful completion of the overall SPORE goals and the requirements of the NCI and all other regulatory bodies including Moffitt, USF, the State of Florida and the FDA are met. Importantly, the Administrative Core C will coordinate the dissemination of information about the Developmental Research and Career Development Programs and oversee the reviews of those projects as well as the progress reports required. It will also provide for yearly retreats and meetings of the internal lAC and external EAB meetings. It will provide the logistic capability necessary for development and support of all projects, cores, and programs, and it will integrate patient advocacy as a vital component of laboratory and clinical skin cancer research. Administrative Core C includes personnel who are not specifically listed or budgeted within individual research projects. However, these personnel, who are listed in the Budget Justification section are vital to the successful function of the Moffitt Skin SPORE, and are required across all projects.

管理/临床试验核心C将用于促进SPORE研究者之间的沟通和管理互动，以及SPORE成员与Moffitt的其他研究和管理单位以及与NCI之间的沟通和互动。核心C将为所有4个项目、3个核心以及发育研究和职业发展计划提供组织和财务监督，并为Moffitt Skin SPORE不可或缺的所有4项黑色素瘤试验提供临床试验协调和数据管理支持。它包括对数据管理员和临床试验协调员的支持，这对SPORE试验的性能至关重要。行政核心C还包括对管理员和助理的支持，管理员和助理将全面负责成功开展所有SPORE活动，包括财务监督和协调、宣传和记录保存，并将严格协调Moffitt Skin SPORE运行中的监管和监督活动的整合。这将确保满足成功完成SPORE总体目标的所有管理要求以及NCI和所有其他监管机构（包括Moffitt、USF、佛罗里达州和FDA）的要求。重要的是，行政核心C将协调有关发展研究和职业发展方案的信息传播，并监督对这些项目的审查以及所需的进度报告。它还将提供每年的务虚会和内部法律咨询委员会会议以及外部EAB会议。它将为所有项目，核心和计划的开发和支持提供必要的后勤能力，并将患者宣传作为实验室和临床皮肤癌研究的重要组成部分。行政核心C包括未在个别研究项目中具体列出或预算的人员。但是，这些人员（列在预算合理性部分）对Moffitt Skin SPORE的成功运行至关重要，并且在所有项目中都是必需的。