Clinical & Biostats Core

临床

• 批准号: 10247733
• 负责人: HELEN E HESLOP
• 金额: $ 15.75万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10247733
• 关键词: Address; Adverse event; Annual Reports; Biological Products; Biometry; Biostatistics Core; Cancer Center; Clinical; Clinical Data; Clinical Research; Clinical Research Protocols; Clinical Trials; Clinical Trials Support Unit; Collaborations; Complex; Comprehensive Cancer Center; Conduct Clinical Trials; Consent Forms; Consultations; Data; Data Analyses; Data Collection; Data Reporting; Databases; Enrollment; Ensure; Futility; Good Clinical Practice; Human Resources; Individual; Infrastructure; Institutional Review Boards; Intranet; Lymphoma; Medicine; Monitor; Notification; Nursing Research; Outcome; Patient Care; Patient Recruitments; Patients; Physicians; Preparation; Principal Investigator; Procedures; Protocol Compliance; Protocols documentation; Quality Control; Randomized; Regulation; Regulatory Affairs; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Research Support; Resource Sharing; Review Committee; Safety; Services; Statistical Methods; Statistical Study; System; Toxic effect; Training; United States National Institutes of Health; Update; Work; base; care providers; clinical development; college; data management; design; experience; experimental study; informatics shared resource; meetings; operation; pre-clinical; preclinical study; programs; protocol development; quality assurance; research study; searchable database; web site

PROJECT SUMMARY This core provides all projects with centralized clinical trial support and provides 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, FDA and NIH/ORDA and the subsequent annual reports and adverse event notifications as required. This core has extensive experience with IND submissions, successfully submitting 66 studies of complex biological agents on 32 INDs: the 30 completed studies have enrolled over 600 patients. The Study Co-ordination group arranges meetings of investigators, attending physicians, research nurses and data managers; provides training on the SOPs for each protocol; and offers research nurse 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 DLDCC Data Review Committee 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.

项目摘要 该核心为所有项目提供了集中的临床试验支持，并提供了基础设施 人员和服务对于安全有效地支持此类研究至关重要，以满足良好的临床 练习（GCP）标准。核心服务将在监管事务，研究协调，质量中提供 保证（QA）和控制（QC）和数据安全监控（DSM）利用临床研究 Dan L Duncan综合癌症中心（DLDCCC）的基础设施 药品。监管事务组件与调查人员合作开发和提交全部 要求监管文件，包括向IRB，IBC，FDA和 NIH/ORDA以及随后的年度报告和不良事件通知。这个核心有 在IND提交中的丰富经验，成功地提交了66个对复杂生物剂的研究 在32个IND上：30项完成的研究已招募了600多名患者。研究协调组 安排调查人员的会议，主治医师，研究护士和数据经理；提供 在SOP上为每个协议进行培训；并提供研究护士的支持，以确保临床研究是 使用ONCORE临床试验管理安全，准确，准确地符合GCP标准 系统。 QC计划将确保协议开发的标准操作程序， 遵循临床试验，数据收集和临床试验管理的进行。质量检查计划将 在入学后，审核每项研究；随后的审计以随机方式进行，以确保 该研究遵循良好的临床实践。数据安全监控是通过DLDCC数据提供的 根据NCI批准的数据安全监控计划运营的审查委员会，该计划负责 审查和评估毒性以及与临床研究相关的任何其他与安全有关的数据 研究。最后，核心为项目提供了全面和集中的生物统计学支持 临床前和临床研究的研究设计，数据分析和数据管理。集中 生物统计支持有助于有效地利用这些服务，并促进 生物统计学家和研究人员在设计，进行，分析和解释所有项目的结果。 这样可以确保进行高质量的项目，以结合适当和最先进的统计 从设计到分析的方法。