Clinical Protocol and Data Management

项目总结/摘要 临床方案和数据管理（CPDM）为教职员工提供集中服务 在悉尼金梅尔综合癌症中心（SKCCC）进行临床研究， 效率和法规遵从性。CPDM支持所有SKCCC研究站点，并维护100多个 标准操作程序（SOP）。由20多名全职员工组成，并监督184项研究 作为临床研究组（CRG）内的护士/协调员，CPDM与CRG密切合作， 管理一个强大的癌症临床试验组合，优先考虑机构和外部同行评审的试验， 并补充SKCCC患者集水区。CPDM有三个业务部门， 由一名经理监督：运营、合规和协调中心。CPDM的管理 由CPDM总监和临床研究副总监负责。的操作 该小组支持250名研究人员，监督467项干预性研究和296项非干预性研究， 这些信息通过一个集中的储存库进行存储和跟踪，该储存库有助于协议的有效流动， 以全系统综合办法收集相关数据。从2016年到2020年，8，234项应计费用用于干预性试验 (7.5比2011-2015年增加%），占我们年度登记案件的26%。的 68%是治疗性试验。CPDM QA小组审查了108项研究，共141项审查， 监督100项新药研究申请，并提供持续的教育和指导。的 协调中心管理了29项多中心试验和132个外部研究中心。CRG由教师CRG领导 主任和经理，团结研究人员围绕其多学科疾病的重点，开展临床 research.该CPDM支持委员会，促进质量审查，从事教师和工作人员在业务 效率，并领导传播改进的论坛。CPDM提供各种教育系列，广告 特别会议和新的教师，研究员和工作人员入职。CPDM在行政上支持 独立的方案审查和监测系统以及安全性监测委员会。一个体制 数据安全监查委员会审查所有随机临床研究以及高风险机构和外部研究 同行评议的研究。将妇女和少数民族纳入SKCCC临床试验仍然是 领导和教师。负责多样性和包容性的助理主任与 社区外展和参与以及CPDM收集和分析应计数据，制定SOP， 改进应计制，并在招聘和保留做法中促进文化谦逊。少数民族的融入 与在SKCCC寻求护理的个人的多样性相匹配。另有193名非洲人 与前五年相比，美国人参与了干预性试验。将个人包括在内 在临床研究的整个生命周期中，这是我们对服务领域的一项重要承诺。参与 在我们广泛的临床试验组合中，儿童、服务不足和老年癌症患者的情况很明显。

PROJECT SUMMARY/ABSTRACT Clinical Protocol and Data Management (CPDM) provides centralized services to faculty and staff conducting clinical research at the Sidney Kimmel Comprehensive Cancer Center (SKCCC), fostering efficiency and regulatory compliance. The CPDM supports all SKCCC research sites and maintains over 100 standard operating procedures (SOPs). Comprising over 20 FTEs centrally and oversight of 184 Research Nurses/Coordinators within the Clinical Research Groups (CRGs), the CPDM works closely with the CRGs to manage a robust cancer clinical trial portfolio that prioritizes institutional and externally peer-reviewed trials, and complements the SKCCC patient catchment area. The CPDM has three operational sections, each supervised by a manager: Operations, Compliance and the Coordinating Center. Administration of the CPDM is the responsibility of the CPDM Director and the Associate Director for Clinical Research. The Operations group supports 250 investigators and oversees 467 interventional and 296 non-interventional studies, all of which are stored and tracked through a centralized repository that contributes to the efficient flow of protocol- related data in a system-wide integrated approach. From 2016–2020, 8,234 accruals to interventional trials (7.5% increase over 2011–2015) were managed, representing 26% of our annual registry cases. Of the accruals, 68% were to therapeutic trials. CPDM QA group reviewed 108 studies with a total of 141 reviews, oversaw 100 Investigational New Drug applications, and provided ongoing education and guidance. The Coordinating Center managed 29 multisite trials with 132 external sites. The CRGs, led by faculty CRG Directors and Managers, unite research staff around their multidisciplinary disease focus to conduct clinical research. The CPDM supports committees that promote quality review, engage faculty and staff in operational efficiency, and lead forums that disseminate improvements. The CPDM provides various educational series, ad hoc sessions and onboarding for new faculty, fellows and staff. The CPDM administratively supports the independent Protocol Review and Monitoring System and the Safety Monitoring Committee. An institutional Data Safety Monitoring Board reviews all randomized clinical studies and high-risk institutional and externally peer-reviewed studies. Inclusion of women and minorities in SKCCC clinical trials remains a major focus of leadership and faculty members. The Assistant Director for Diversity and Inclusion works with the Office of Community Outreach and Engagement and the CPDM to collect and analyze accrual data, develop SOPs to improve accrual, and promote cultural humility in recruitment and retention practices. Minority inclusion consistently matches the diversity of the individuals seeking care at the SKCCC. An additional 193 African Americans participated in interventional trials compared to the prior five years. The inclusion of individuals across the life span in clinical research is an important commitment to our catchment area. Participation of children, underserved and aging cancer patients is apparent across our broad portfolio of clinical trials.