Administrative, Regulatory and Cord Blood Bank

这个核心的目标是为所有项目和其他核心提供集中的领导、行政管理。脐带血库和临床研究支持。行政部门将负责整合方案项目赠款(PO1)的所有组成部分，并监督进展情况，以便实现研究目标。它将就预算问题向每个项目和核心领导人提供援助，并监督该方案的总体财政和预算管理。该核心还将通过召开内部和外部咨询委员会会议并执行其建议来协调对PO1的监督。这一核心的临床研究部分的目标是与核心B合作，为所有项目提供临床试验支持，并提供充分支持此类研究的人员和服务基础设施。将在监管事务、研究协调、质量保证和控制以及数据安全监测方面提供核心服务。监管事务部门与调查人员合作，制定和提交所有必要的监管文件，包括向IRB、IBC、FDA和NIH/OBA提交的文件和年度报告。该核心在IND提交方面有丰富的经验，目前支持超过45项IND研究。质量控制程序将确保准确定义并遵循用于制定方案、进行临床试验、收集数据和管理临床试验的标准操作程序。质量保证计划将在第一个患者登记参加研究后进行审计，然后随机进行，以确保研究是按照良好的临床实践进行的。MD Anderson脐带血库致力于为临床前同行评议研究提供脐带血单位，以推动脐带血移植领域的发展，并将提供执行项目中建议的研究所需的所有脐带血单位。在这个PO1中，我们开发了克服脐带血移植局限性的战略方法，并将依赖于在精心设计的临床前模型中测试潜在的解决方案，然后将结果转化为临床。

The goals of this core are to provide all projects and the other cores with centralized leadership, administrative. Cord Blood Bank and clinical research support. The Administrative component will be responsible for integrating all components of the program project grant (PO1) and overseeing progress, so that the research objectives are being met. It will provide assistance to each project and core leader with budgetary issues and will oversee the overall fiscal and budgetary management of the program. This Core will also coordinate oversight of the PO1 by convening meetings of the Internal and External Advisory Boards and implementing their recommendations. The goals of the clinical research component of this core are to provide all projects with clinical trial support in collaboration with Core B and provide an infrastructure of personnel and services that will adequately support such research. Core services will be provided in regulatory affairs, study coordination, quality assurance and control and data safety monitoring. The Regulatory Affairs component collaborates with investigators to develop and submit all required regulatory documents, including submissions to the IRB, IBC, FDA, and NIH/OBA and annual reports. This core has extensive experience with IND submission and currently supports over 45 IND studies. The Quality Control program will ensure that standard operating procedures for protocol development, conduct of clinical trials, data collection and management of clinical trials are accurately defined and being followed. The Quality Assurance program will undertake audits after the first patient is enrolled on a study and then randomly to ensure that the studies are being conducted according to Good Clinical Practices. The MD Anderson Cord Blood Bank is committed to providing cord blood units for pre-clinical peer-reviewed research to advance the field of cord blood transplantation, and will provide all the cord blood units needed to execute the studies proposed in the projects. In this PO1 we have developed strategic approaches to overcome the limitations of cord blood transplantation and will rely on testing potential solutions in carefully designed preclinical models and then translating the results to the clinic.