ADMINISTRATIVE AND CLINICAL RESEARCH

核心的目标是为所有项目提供集中领导、行政、生物统计和 临床研究支持。行政部门将负责整合 PPG和监督进展，使研究目标得以实现。为了实现这些目标， CORE将安排内部小组会议，包括每月的调查员会议、执行委员会会议 会议和受邀的研究讲座。它将为每个项目和核心领导提供帮助，包括 他还将负责预算问题，并将监督该方案的总体财政和预算管理。这 CORE还将通过召开内部和外部咨询会议来协调对PPG的监督 董事会并落实他们的建议。这一核心的临床研究部分的目标 为所有项目提供集中的临床试验支持，并提供人员和基础设施 将充分支持此类研究的服务。核心服务将在监管事务中提供， 研究协调、质量保证和控制以及数据安全监测。监管事务 该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/ORDA提交的材料和年度报告。这个核心有广泛的 有提交IND的经验，目前支持超过25项IND研究。质量控制(QC) 该计划将确保制定方案、进行临床试验、 对临床试验的数据收集和管理进行了准确的定义和遵循。QA 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 这些研究是根据良好的临床实践进行的。该核心还将协调数据 由负责审查和评估毒性和任何 本计划中临床研究研究的其他与研究相关的安全相关数据。生物统计学 该构成部分将提供全面和集中的支持，整合下列生物统计活动 这个PPG中的研究项目。它将协调和管理方案的统计活动，以 确保研究人员随时可以获得生物统计学咨询；在以下方面提供生物统计学专业知识 临床试验和临床前验证实验的研究计划和实施，协调数据 管理活动，并为包括安全性/毒性在内的数据分析提供全面支持 监测、数据中期审查、最终分析和报告。生物统计核心人员将 在研究计划和开发中纳入合理的实验原则，实施协调的数据 管理系统，并促进提供及时和高质量的统计分析和数据 释义。

The goals of the core are to provide all projects with centralized leadership, administrative, biostatistical and clinical research support. The Adminstrative component will be responsible for integrating all components of the PPG and overseeing progress, so that the research objectives are being met. To achieve these goals the core will arrange internal group meetings including the monthly investigator meeting, executive committee meetings and invited research lectures. It will provide assistance to each project and core leader with budgetary issues and will also oversee the overall fiscal and budgetary management of the program. This core will also co-ordinate oversight of the PPG by convening meetings of the Internal and External Advisory Boards and implementing their recomendations. The goals of the clinical research component of this core are to provide all projects with centralized clinical trial support 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/ORDA and annual reports. This core has extensive experience with IND submission and currently supports over 25 IND studies. The Quality Control (QC) 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 QA 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 core will also co-ordinate data monitoring by the Data Review Committee which is responsible for reviewing and evaluating toxicity and any other study-relevant safety-related data for clinical research studies in this program. The Biostatistics component will provide comprehensive and centralized support that integrates the biostatistical activities of the research projects in this PPG. It will coordinate and manage the statistical activities of the program to ensure that investigators have ready access to biostatistical consultation; provide biostatistical expertise in study planning and conduct of clinical trials and preclinical validation experiments, coordinate data management activities and provide comprehensive support for data analysis including safety/toxicity monitoring, interim reviews of data, final analysis, and reporting. The Biostatistics Core personnel will incorporate sound experimental principles in study planning and development, implement a coordinated data management system, and facilitate provision of timely and high-quality statistical analysis and data interpretation.