Administrative, Regulatory and Cord Blood Bank

行政、监管和脐带血库

• 批准号: 8555385
• 负责人: Elizabeth J Shpall
• 金额: $ 11.11万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-22 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8555385
• 关键词: Accounting; Address; Annual Reports; Biotechnology; Blood Banks; Budgets; Clinic; Clinical; Clinical Research; Clinical Research Protocols; Clinical Trials; Collaborations; Commit; Communication; Conduct Clinical Trials; Controlled Study; Data; Data Collection; Development; Disadvantaged; Disputes; Dose; Engraftment; Enrollment; Ensure; Environment; Equilibrium; Freezing; Funding; Funding Agency; Goals; Good Clinical Practice; Grant; Human Resources; Immune; Institutional Review Boards; Investigational Drugs; Leadership; Medical center; Minority; Monitor; Patients; Pre-Clinical Model; Procedures; Program Research Project Grants; Protocols documentation; Publications; Quality Control; Recombinant DNA; Recommendation; Regulatory Affairs; Report (account); Reporting; Research; Research Infrastructure; Research Peer Review; Research Personnel; Research Project Grants; Research Support; Resource Sharing; Resources; Safety; Services; Solutions; Source; Stem cells; Supervision; Testing; Texas; Translating; Translations; Transplantation; Umbilical Cord Blood; Umbilical Cord Blood Transplantation; United States Food and Drug Administration; United States Health Resources and Services Administration; United States National Institutes of Health; University of Texas M D Anderson Cancer Center; Validation; Visit; data management; design; experience; improved; meetings; operation; pre-clinical; preclinical study; programs; protocol development; quality assurance; reconstitution; stem

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.

该核心的目标是为所有项目和其他核心提供集中领导和管理。脐带血库和临床研究支持。行政部门将负责整合计划项目拨款（PO1）的所有组成部分并监督进展，以便实现研究目标。它将向每个项目和核心领导提供预算问题方面的帮助，并将监督该计划的整体财政和预算管理。该核心还将通过召开内部和外部顾问委员会会议并实施其建议来协调 PO1 的监督。该核心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。监管事务部门与研究人员合作制定并提交所有必需的监管文件，包括向 IRB、IBC、FDA 和 NIH/OBA 提交的文件以及年度报告。该核心在 IND 提交方面拥有丰富的经验，目前支持超过 45 项 IND 研究。质量控制计划将确保准确定义并遵循方案制定、临床试验实施、数据收集和临床试验管理的标准操作程序。质量保证计划将在第一位患者参加研究后进行审核，然后随机进行审核，以确保研究是根据良好临床实践进行的。 MD 安德森脐带血库致力于为临床前同行评审研究提供脐带血单位，以推进脐带血移植领域的发展，并将提供执行项目中提出的研究所需的所有脐带血单位。在本次 PO1 中，我们制定了克服脐带血移植局限性的战略方法，并将依靠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。