Administration and Clinical Trial Coordination

管理和临床试验协调核心A将作为该计划的中心组织枢纽。该核心将有5个主要功能： 1)协调项目的行政和财务管理; 2)通过内部项目成员和外部顾问的会议提供研究协调和审查; 3)通过在IRB互动、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方面提供一致性，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的患者的随访; 5)确保男女和所有少数民族都能参加临床试验。 核心委员会将对项目进行监督和财务管理，并通过在这些领域具有专门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的组织对这一工作进行中央协调，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FDA的关键作用。 核心的集中这项工作将为这些工作提供专门知识和一致性。核心将组织和促进一个外部顾问小组，他们将每年访问该计划并提供批评和指导。每月的计划项目会议也将由核心组织。核心领导人将与分区、部门和癌症中心人员联络，以加强互动， 发现。所有项目和核心都将使用核心A功能。

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.