Clinical Research Core

临床研究核心的目标是为所有项目提供集中的临床试验支持和 提供充分支持此类研究的人员和服务基础设施。堆芯 将在监管事务、研究协调、质量保证和控制以及数据方面提供服务 安全监测。监管事务部门与调查人员合作制定和提交 所有必需的法规文件，包括向IRB、IBC、FDA和NIH/ORDA提交的文件，以及年度 报告。此核心具有丰富的IND提交经验，目前支持超过25个IND 学习。 质量控制(QC)计划将确保协议开发的标准操作程序， 临床试验的进行、数据收集和临床试验的管理被准确地定义并被 紧随其后。QA计划将在第一个患者参加研究后进行审计，然后 随机进行，以确保研究按照良好的临床实践进行。核心将会 也负责协调数据审查委员会的数据监测工作 评估毒性和任何其他与临床研究相关的安全相关数据 孢子。 核心还将安排调查人员、主治医生、统计学家、 研究护士、数据经理和适当的护士经理，以确保临床研究 既安全又高效地进行。它还将提供研究护士支持，以便利临床指导 审判。

The goals of the cliniclal research 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 SPORE. The core will also arrange internal group meetings of the investigators, attending physicians, statisticians, research nurse, data manager, and appropriate nurse managers to ensure that the clinical studies are conducted both safely and efficiently. It will also provide research nurse support to faciliate conduct of clinical trials.