Clinical Protocol and Data Management

临床方案和数据管理：综述 第一部分：临床方案和数据管理(CPDM)。医学中心临床试验办公室(CTO) 南卡罗来纳大学霍林斯癌症中心(HCC)由65.5名FTE组成，他们提供 为癌症中心研究人员提供集中研究支持服务。这些服务包括全面的 从方案构思到激活的法规支持、研究新药支持、注册 在ClinicalTrials.gov上进行新的试验和结果报告。首席技术官还优化了对外部同行的应计- 审查、研究人员发起、国家临床试验网络和行业赞助的试验，通过提供 由训练有素的临床研究协调员和数据经理组成的集中核心，到癌症中心研究- 托尔斯。通过培养研究人员-患者-患者-来加强研究协调和方案遵从性 CTO互动、协作和团队合作。首席技术官积极评估协议和法规合规性- 检查和监测数据的准确性和及时性。作为所有与肿瘤学相关的中心数据库 试验活动，首席技术官向癌症中心提供全面的报告和绩效指标 领导适当的监督和战略规划，包括发展培训和教育 临床研究人员和研究人员的倡议以及其他过程改进努力。在……里面 仅2017年，CTO就报告招募了1,520人参加 肝癌(1,266项干预性应计项目和254项非干预性应计项目)，并促进了更多 83项研究，包括19项机构和外部同行评议的研究。 第二部分：数据与安全监控(DSM)。所有干预性研究都需要DSM。为癌症中心服务 由研究人员发起的研究，该中心已经建立了自己的数据和安全监测委员会 (DSMC)，它执行基于风险的监测，以确保最高水平的患者安全。有效质量- 还设立了安全控制功能，以确保最高级别的协议遵从性 美国国家通信委员会批准的数据和安全监测计划(DSMP)。2017年，数字医学中心监测了14项研究， 其中包括对18项审计、14份进度报告和70起严重不良事件的审查。 第三部分：将妇女和少数群体纳入研究。该中心维护和支持多个、 积极努力促进招募妇女和少数群体。2017年，在1520名个人中- 参加所有研究的ALS中，50%是女性，33%代表少数民族和少数族裔。 第四部分：将儿童纳入研究。美国国立卫生研究院支持美国国立卫生研究院关于接纳儿童的政策 在研究方面。肝细胞癌是NCTN儿童肿瘤学小组和其他几个非政府组织的活跃成员。 国家儿科肿瘤学试验联盟。2017年，CTO报告了53名儿童被招募到所有临床 肝细胞癌内的研究(22项干预性和31项非干预性应计)。

CLINICAL PROTOCOL & DATA MANAGEMENT: SUMMARY Part I: Clinical Protocol & Data Management (CPDM). The Clinical Trials Office (CTO) at the Medical University of South Carolina (MUSC) Hollings Cancer Center (HCC) is comprised of 65.5 FTEs who provide centralized research support services to cancer center investigators. These services include comprehensive regulatory support from protocol conception to activation, Investigational New Drug support, registration of new trials, and results reporting with ClinicalTrials.gov. The CTO also optimizes accrual to externally peer- reviewed, investigator-initiated, National Clinical Trials Network, and industrial sponsored trials by providing a centralized core of trained clinical research coordinators and data managers to cancer center investiga- tors. Research coordination and protocol compliance is enhanced through fostering of investigator-patient- CTO interaction, collaboration, and teamwork. The CTO actively assesses protocol and regulatory compli- ance and monitors data accuracy and timeliness. As the central data repository of all oncology-related trial activities, the CTO provides comprehensive reports and performance metrics to the cancer center leadership for proper oversight and strategic planning including the development of training and education initiatives for both clinical research staff and investigators and other process improvement endeavors. In 2017 alone, the CTO reported the recruitment of 1,520 individuals into all clinical research studies within the HCC (1,266 interventional and 254 non-interventional accruals) and has facilitated the activation of more than 83 studies, including 19 institutional and externally peer-reviewed studies. Part II: Data & Safety Monitoring (DSM). DSM is required for all interventional studies. For cancer center investigator-initiated studies, the center has established its own Data & Safety Monitoring Committee (DSMC), which performs risk-based monitoring to ensure the highest levels of patient safety. Effective qual- ity control functions are also instituted to ensure the highest level of protocol compliance according to the HCC’s NCI-approved Data & Safety Monitoring Plan (DSMP). In 2017, the DSMC monitored 14 studies, which included the review of 18 audits, 14 progress reports, and 70 serious adverse events. Part III: Inclusion of Women and Minorities in Research. The HCC maintains and supports multiple, proactive efforts to promote the recruitment of women and minorities. In 2017, among the 1,520 individu- als enrolled onto all studies, 50% were women and 33% represented ethnic and racial minorities. Part IV: Inclusion of Children in Research. The HCC supports the NIH policy on the inclusion of children in research. The HCC is an active member of the NCTN Children’s Oncology Group and several other na- tional pediatric oncology trial consortia. In 2017, the CTO reported the recruitment of 53 children into all clinical research studies within the HCC (22 interventional and 31 non-interventional accruals).