Administration and Clinical Trials

行政/临床试验核心C将促进SPORE研究人员之间、SPORE成员与莫菲特的其他研究和行政单位之间以及与NCI之间的沟通和管理互动。Core C将为所有4个项目、3个核心以及发展研究和职业发展项目提供组织和财务监督，并为莫菲特皮肤孢子项目中所有4个黑色素瘤试验提供临床试验协调和数据管理支持。它包括对数据管理人员和临床试验协调员的支持，他们将对孢子试验的性能至关重要。行政核心C还包括对一名管理员和一名助理的支持，他们将对所有SPORE活动的成功开展负责，包括财务监督和协调，宣传和记录保存，并将在Moffitt Skin SPORE运行中协调监管和监督活动的整合。这将确保成功完成SPORE总体目标的所有行政要求以及NCI和所有其他监管机构（包括Moffitt， USF，佛罗里达州和FDA）的要求都得到满足。重要的是，行政核心C将协调有关发展研究和职业发展计划的信息传播，并监督这些项目的审查以及所需的进度报告。它还将提供年度务静会和内部拉加经委会会议和外部拉加经委会会议。它将为所有项目、核心和项目的发展和支持提供必要的后勤能力，并将患者倡导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包括在个别研究项目中没有具体列出或预算的人员。然而，在预算论证部分列出的这些人员对于Moffitt Skin SPORE的成功功能至关重要，并且所有项目都需要这些人员。

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.