Core B: Clinical Research

项目总结 该核心为所有项目提供集中的临床试验支持和人员和基础设施 安全有效地支持此类研究以满足良好临床实践(GCP)所必需的服务 标准。将在监管事务、研究协调、质量保证(QA)方面提供核心服务 和控制(QC)和数据安全监控(DSM)，利用DAN的临床研究基础设施 L，贝勒医学院邓肯综合癌症中心。监管事务 该部门与调查人员合作，制定和提交所有必要的管理文件，包括 提交给IRB、IBC和FDA的初始和修订的报告以及随后的年度报告和不利的 根据需要发送事件通知。这一核心拥有丰富的IND提交经验，成功 在50多个IND上提交100多项复杂生物制剂的研究：完成的研究有 招募了1200多名患者。研究协调小组安排调查人员会议，参加 医生、研究护士和数据管理员；提供有关标准操作程序的培训 (标准操作程序)；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、准确和高效地达到GCP标准。这个 QC计划将确保按标准操作程序制定方案，进行临床 跟踪临床试验的试验、数据收集和管理。QA计划将审核每项研究 在第一个患者入选后，随后的审核将以随机方式进行，以确保后续研究 良好的临床实践。数据安全监控通过DLDCCC数据审查委员会或 在NCI批准的数据安全监控计划下运行的外部DSMB，负责 为临床研究审查和评估毒性和任何其他与研究相关的安全相关数据。 最后，核心为包括研究在内的项目提供全面和集中的生物统计支持 临床前和临床研究的设计、数据分析和数据管理。集中生物统计学 支持促进了这些服务的有效使用，并促进了生物统计学家和 调查员参与设计、实施、分析和解释所有项目的结果。这确保了 实施高质量的项目，将适当和最先进的统计方法纳入其 根据他们的分析进行设计。

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.