Core B: Clinical Research

项目摘要 该核心为所有项目提供集中的临床试验支持和人员基础设施， 安全有效地支持此类研究以符合药物临床试验质量管理规范（GCP）的必要服务 标准将在法规事务、研究协调、质量保证（QA）方面提供核心服务 和控制（QC）和数据安全监测（DSM），利用丹的临床研究基础设施 贝勒医学院L邓肯综合癌症中心（DLDCCC）。法规事务 组件与研究者合作，制定并提交所有必要的监管文件，包括 向IRB、IBC和FDA提交的初始和修订版提交材料以及随后的年度报告和不良反应报告 根据需要通知事件。该核心具有丰富的IND提交经验，成功地 提交了100多项关于50多个IND的复杂生物制剂的研究：已完成的研究 招募了1200多名患者。研究协调小组安排研究者会议， 医生、研究护士和数据管理员;提供标准作业程序培训 （SOP）;并提供研究协调员支持，以确保进行临床研究 使用OnCore临床试验管理系统安全、准确、高效地达到GCP标准。的 QC计划将确保方案制定的标准操作规程、临床试验的开展 遵循临床试验、数据收集和管理。QA项目将稽查每项研究 第一例患者入组后;后续稽查以随机方式进行，以确保研究遵循 良好临床实践。通过DLDCCC数据审查委员会或 外部DSMB根据NCI批准的数据安全性监测计划运行，负责 审查和评价临床研究的毒性和任何其他研究相关的安全性相关数据。 最后，核心为项目提供全面和集中的生物统计支持，包括研究 临床前和临床研究的设计、数据分析和数据管理。集中生物统计 支持有助于有效利用这些服务，并促进生物统计学家和 调查人员参与所有项目的设计、实施、分析和结果解释。这确保 开展高质量的项目，其中包括适当的和最先进的统计方法， 设计他们的分析。

PROJECT SUMMARY This core provides all projects with centralized clinical trial support and the infrastructure of personnel and services essential to safely and effectively support such research to meet Good Clinical Practice (GCP) standards. Core services will be provided in Regulatory Affairs, Study Co-ordination, Quality Assurance (QA) and Control (QC) and Data Safety Monitoring (DSM) leveraging the clinical research infrastructure of the Dan L Duncan Comprehensive Cancer Center (DLDCCC) at Baylor College of Medicine. The Regulatory Affairs component collaborates with investigators to develop and submit all required regulatory documents, including initial and revised submissions to the IRB, IBC, and FDA and the subsequent annual reports and adverse event notifications as required. This core has extensive experience with IND submissions, successfully submitting over 100 studies of complex biological agents on over 50 INDs: the completed studies have enrolled over 1200 patients. The Study Co-ordination group arranges meetings of investigators, attending physicians, research nurses and data managers; provides training on the standard operating procedures (SOPs) for each protocol; and offers research coordinator support to ensure that clinical studies are conducted safely, accurately and efficiently to GCP standards using the OnCore clinical trials management system. The QC program will ensure that the standard operating procedures for protocol development, conduct of clinical trials, data collection and management of clinical trials are followed. The QA program will audit each study after the first patient is enrolled; subsequent audits are held in a randomized way to ensure that studies follow Good Clinical Practices. Data Safety monitoring is provided through the DLDCCC Data Review Committee or external DSMB operating under an NCI-approved data safety monitoring plan, which is responsible for reviewing and evaluating toxicity and any other study-relevant safety-related data for clinical research studies. Finally, the core provides comprehensive and centralized biostatistical support to projects including study design, data analysis and data management for preclinical and clinical studies. Centralized biostatistical support facilitates efficient use of these services and promotes collaboration between biostatisticians and investigators in the design, conduct, analysis and interpretation of results for all projects. This ensures the conduct of high-quality projects that incorporate appropriate and state-of-the-art statistical methods from their design to their analysis.