Clinical Protocol and Data Management

临床方案和数据管理（CPDM） 摘要 临床方案和数据管理（CPDM）由加州大学洛杉矶分校Jonsson的Dennis Slamon，MD，PhD（STT）领导 综合癌症中心（JCCC）临床/转化研究副主任。CPDM功能 完全位于JCCC临床研究部门（CRU）内，由JCCC主任Michael直接授权 Teitell，MD，PhD（CMINT）. CRU的总体目标及其具体目标是确保获得 在整个JCCC集水区、洛杉矶县（LAC）开展肿瘤患者临床试验，以及 除此之外，进一步发展临床/转化肿瘤学科学，并提供新的有效的FDA批准的 治疗广泛使用。CRU提供必要的基础设施，以执行重要和有影响力的 临床/转化研究。JCCC主任和UCLA研究领导层之间的牢固关系 使该中心能够建立肿瘤学研究的最高标准。由梅根·布伦南领导的CRU， RN，MSN，ONP，PhD，JCCC肿瘤临床研究高级主任，为所有UCLA/JCCC教师服务 进行癌症相关的临床研究。240名员工支持60多名校长 作为研究者，CRU每年监督和管理500多项干预性试验。CRU已经 方案制定、向联邦和机构实体提交法规的集中支持职能， 研究启动和执行、数据和安全性报告、监查、稽查和法规遵从性。的 JCCC，通过数据和安全监测委员会（DSMB）和CRU法规合规办公室 (ORC)，为介入性机构试验提供监督、数据和安全性评价。JCCC确保 所有临床试验设计均具有科学完整性，具有临床和科学相关性，解决安全性问题 问题，并根据州，联邦和机构政策的性能。此外，JCCC 将这些标准应用于来自内部和外部赞助商的所有临床研究。 在Teitell的领导下，JCCC临床/转化科学和CRU已经发展并经历了转型 短时间内的变化。泰特尔与斯拉蒙和布伦南一起工作，迅速确定了挑战， 影响试验累积性能和入选的新机会的可能性。立即，Teitell 获得约180万美元的额外机构资金，以制定和支持新的包容性举措，更新和 增强CRU基础设施，并为JCCC成员增加更多的集中计划。在下一个项目中 在此期间，扩大了JCCC临床研究活动，重点是纳入和增加妇女， 少数民族、儿童和拉丁美洲和加勒比地区及其他地区服务不足的人口是布伦南的最高优先事项， 斯拉蒙JCCC通过四个新的项目，在一个更全面的包容性计划上投入了大量资金。 在其集水区的多样性倡议，包括伯班克妇科肿瘤倡议，范奈斯 乳腺癌计划，橄榄景医疗中心（OVMC）计划，和米勒儿童和妇女的 医院长滩合作。

CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) ABSTRACT Clinical Protocol and Data Management (CPDM) is led by Dennis Slamon, MD, PhD (STT), UCLA Jonsson Comprehensive Cancer Center (JCCC) Associate Director for Clinical/Translational Research. CPDM functions reside fully within the JCCC Clinical Research Unit (CRU) under the direct authority of JCCC Director, Michael Teitell, MD, PhD (CMINT). The overarching objective of the CRU and its specific goals are to ensure access to clinical trials for oncology patients throughout the JCCC catchment area, Los Angeles County (LAC), and beyond, to further the science of clinical/translational oncology, and to provide new and effective FDA-approved therapies for widespread use. The CRU provides the necessary infrastructure to execute important and impactful clinical/translational studies. A strong relationship between the JCCC Director and UCLA research leadership enables the Center to establish the highest standards for oncology research. The CRU, led by Meghan Brennan, RN, MSN, ONP, PhD, JCCC Senior Director for Oncology Clinical Research, serves all UCLA/JCCC faculty conducting cancer-related clinical research. With 240 staff members supporting more than 60 principal investigators, the CRU oversees and manages more than 500 interventional trials annually. The CRU has centralized support functions for protocol development, regulatory submission to federal and institutional entities, study activation and execution, data and safety reporting, monitoring, auditing, and regulatory compliance. The JCCC, through the Data and Safety Monitoring Board (DSMB) and the CRU Office of Regulatory Compliance (ORC), provides oversight, data, and safety evaluations for interventional institutional trials. The JCCC ensures that all clinical trials design is with scientific integrity, having clinical and scientific relevance, addressing safety issues, and with performance according to state, federal, and institutional policies. Furthermore, the JCCC applies these standards to all clinical research, from both internal and external sponsors. Under Teitell, JCCC clinical/translational science and the CRU have grown and undergone transformational changes in a short period. Working together with Slamon and Brennan, Teitell quickly identified challenges and the potential for new opportunities influencing trial accrual performance and inclusion. Immediately, Teitell secured ~$1.8 M in additional institutional funding to develop and support new inclusion initiatives, update and augment the CRU infrastructure, and add more centralized programs for JCCC members. In the next project period, the expansion of JCCC clinical research activity with a focus on inclusion and accrual of women, minorities, children, and underserved populations in LAC and beyond are the highest priorities for Brennan and Slamon. The JCCC has invested substantially in a more comprehensive inclusion program through four new diversity initiatives in its catchment area, including the Burbank Gynecology Oncology Initiative, the Van Nuys Breast Cancer Program, the Olive View Medical Center (OVMC) Program, and Miller Children’s and Women’s Hospital Long Beach Partnership.