Clinical Trials Core

SCC临床试验核心（CTC）为Siteman癌症中心研究人员提供关键支持， 癌症临床研究。CTC的目标是通过提供一个 有效、高效、经济的临床研究团队，高度专业化的癌症研究。 通过CTC，可为方案制定、监管和管理的所有方面提供全面服务。 提交、研究协调、数据管理以及教育和培训，所有这些都至关重要 促进SCC在转化临床研究方面的发展。 方案制定人员在以下领域提供专业知识和研究援助： 设计;方案和同意书的编写和编辑;促进生物统计支持; 开发数据收集方法;促进研究定义的数据库工具的开发。 监管服务包括所有监管事务的管理。这些服务包括协议 提交和处理;试验结束;方案审查和监测委员会（PRMC），质量 保证和安全监测委员会（QASMC）和人类研究委员会（HSC，WU IRB） 提交;向FDA提交IND申请;以及与其他监管机构的互动 和机构办公室[NIH重组DNA咨询委员会（RAC），机构生物安全 委员会（IBC）），辐射安全委员会（RSC）;放射性药物研究委员会（RDRC）， 临床研究中心（CCS），技术管理办公室（OTM）] 研究协调包括试验实施和数据管理的所有方面的服务， 不限于：试验后勤评估;资格验证;研究协调;数据收集;记录 保留;数据安全和监查报告;稽查和监查准备;不良事件 评估和报告;以及完成数据汇总以供分析。 临床试验工作人员的教育和培训是通过积极的方向，培训， 跟踪程序。此外，该计划还为员工提供继续教育的机会。 反恐委员会工作人员目前可持续获得这项服务。反恐委员会还协助 调查员负责确定潜在的资金来源、编制预算和合同以及其他 研究相关活动，并提供临床试验工具（例如，SCC协议索引、Web帖子和 以电子方式查阅议定书文件）。

The SCC Clinical Trials Core (CTC) provides critical support to Siteman Cancer Center investigators for cancer clinical research. The goal of the CTC Is to facilitate translational research by providing access to an effective, efficient, and economical clinical research team highly specialized in cancer research. Comprehensive services are available through the CTC for all aspects of protocol development, regulatory submissions, study coordination, data management and education and training, all of which will be essential for the SCC's growth in translational clinical research. ¿ Protocol development staff provide expertise and research assistance in the following areas: study design; protocol and consent form development and editing; facilitating biostatistical support; development of data collection methods; and facilitating development of study-defined database tools. ¿ Regulatory services include management of all regulatory affairs. These services include protocol submission and processing; trial close-out; Protocol Review & Monitoring Committee (PRMC), Quality Assurance & Safety Monitoring Committee (QASMC), and Human Studies Committee (HSC, WU IRB) submissions; assembling IND applications to the FDA ; and interaction with other regulatory agencies and institutional offices [NIH Recombinant DNA Advisory Committee (RAC), Institutional Biosafety Committee (IBC)), Radiation Safety Committee (RSC); Radioactive Drug Research Committee (RDRC), Centerfor Clinical Studies (CCS), Office of Technology Management (OTM)] ¿ Studv coordination includes services in all aspects of trial conduct and data management, including but not limited to: trial logistics assessment; eligibility verification; study coordination; data collection; record retention; data safety and monitoring reporting; audit and monitoring preparation; adverse event assessment and reporting; and data summary completion for analysis. ¿ Education and Training of the Clinical Trials staff is provided by an aggressive orientation, training, and tracking program. Additionally, the program provides continuing education opportunities to the staff. This service is currently available to the CTC staff on an ongoing basis. The CTC also assists investigators with identifying potential funding sources, budget and contract development and other study-related activities, and provides clinical trials tools (e.g., SCC protocol Index, Web postings and electronic access to protocol documents).