Clinical Protocol and Data Management (Core 012)

临床方案和数据管理（核心 012）

• 批准号: 9359388
• 负责人: DAN TOBY VOGL
• 金额: $ 88.99万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9359388
• 关键词: Address; Affect; African American; Award; Biology; Cancer Burden; Cancer Center; Cancer Center Support Grant; Catchment Area; Child; Childhood; Clinical Data; Clinical Investigator; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Collection; Colorectal Cancer; Community Outreach; Complex; Conduct Clinical Trials; Data; Development; Disease; Ensure; Goals; Healthcare Systems; Home environment; Human; Human Subject Research; Improve Access; Incidence; Institutional Policy; Intervention; Knowledge; Leadership; Malignant Childhood Neoplasm; Malignant Neoplasms; Malignant neoplasm of lung; Minority; Monitor; Monitoring Clinical Trials; Nursing Research; Patients; Pediatric Oncology; Pediatric Research; Play; Policies; Population; Procedures; Protocols documentation; Recruitment Activity; Regulation; Reporting; Research; Review Committee; Role; Safety; Screening for cancer; Services; Source; Specimen; Supervision; System; Testing; Training; Training and Education; Underserved Population; Update; Woman; cancer clinical trial; cancer health disparity; community organizations; data management; design; disparity reduction; expectation; experience; improved; malignant breast neoplasm; medical specialties; mortality; oncology program; programs; quality assurance; research study; safety study; tumor

Project Summary Clinical Protocol and Data Management (CPDM) is the administrative home for all of the units that support clinical research at the Abramson Cancer Center (ACC), providing essential support for and monitoring of all clinical research conducted in the ACC regardless of the type of intervention or sponsor. The CPDM, in collaboration with ACC Leadership, creates, directs and enforces the operational standards (policies) and expectations for the conduct of all clinical research within the ACC. The CPDM scope is of necessity broad, encompassing development and updating of policies and procedures, education and training, supervision of data managers and research nurses, and oversight over all of the specialty clinical research units within our Center. The CPDM manages our centralized Clinical Trials Management System (CTMS), Velos, organizes and performs quality assurance and QC/monitoring of clinical trials across the center, and directly manages the complex, ongoing and recurring activities of our mandatory clinical research review committees. Key units supported by the CPDM are the Department of Compliance and Monitoring (DOCM), the Protocol Review and Monitoring System (PRMS, known as the Clinical Trials Scientific Review and Monitoring Committee [CTSRMC]), the Data and Safety Monitoring Committee (DSMC), and the Clinical Research Unit (CRU). While CPDM provides the administrative support for PRMS and DSMC, it is vital to note that these are, by design, distinct entities. PRMS is described elsewhere in this renewal. The inclusion of Women and Minorities in clinical trials is a central focus of ACC Leadership and clinical investigators as a component of our commitment to addressing the cancer burden in minority and underserved populations. During the current award period, the ACC implemented several initiatives aimed at reducing disparities in cancer incidence and mortality in minorities, including completion of quality improvement training to further increase the diversity of the patients on cancer clinical trials at ACC, establishment of additional key partnerships with community organizations to increase educational efforts and community outreach, creation of cancer screening navigation programs that increase patient engagement and improve access to and completion of cancer screening tests, and recruitment of a cadre of patient navigators for common diseases in our catchment area affecting minorities, including lung, colorectal and breast cancer, in order to assist patients from all backgrounds in getting into our health care system and using it effectively. Children with cancer have traditionally had a very high participation rate in clinical research studies with the field of pediatric oncology often at the forefront of cancer clinical research. The ACC Pediatric Oncology Program has played a central role locally and nationally in improving our understanding of the biology of childhood cancers through the collection and study of human tumor specimens, and in advancing our knowledge of optimal treatments by conducting clinical trials and playing a very notable leadership role in national pediatric cooperative group and clinical research consortia.

项目概要 临床方案和数据管理 (CPDM) 是所有支持该项目的单位的管理中心 艾布拉姆森癌症中心 (ACC) 的临床研究，为所有研究提供必要的支持和监测 无论干预措施或赞助商的类型如何，都在 ACC 中进行临床研究。 CPDM，在 与 ACC 领导层合作，制定、指导和执行运营标准（政策）和 对 ACC 内所有临床研究进行的期望。 CPDM 的范围必然很广泛， 包括制定和更新政策和程序、教育和培训、监督 数据经理和研究护士，以及对我们内部所有专业临床研究单位的监督 中心。 CPDM 管理我们的集中临床试验管理系统 (CTMS) Velos，组织 并对整个中心的临床试验进行质量保证和质量控制/监控，并直接管理 我们的强制性临床研究审查委员会的复杂、持续和重复的活动。重点单位 CPDM 的支持机构包括合规与监测部 (DOCM)、方案审查和 监测系统（PRMS，全称为临床试验科学审查和监测委员会 [CTSRMC]）、数据和安全监测委员会 (DSMC) 以及临床研究单位 (CRU)。 虽然 CPDM 为 PRMS 和 DSMC 提供管理支持，但值得注意的是，这些支持是通过 设计，独特的实体。 PRMS 在本次更新的其他地方进行了描述。妇女的包容性和 临床试验中的少数群体是 ACC 领导层和临床研究人员的核心关注点，作为 我们致力于解决少数群体和服务不足人群的癌症负担。当前期间 在颁奖期间，ACC 实施了几项旨在减少癌症发病率差异的举措 少数民族死亡率，包括完成质量改进培训，以进一步增加少数民族的多样性 在 ACC 进行癌症临床试验的患者，与社区建立额外的重要合作伙伴关系 组织加大教育力度和社区外展，创建癌症筛查导航 提高患者参与度并改善癌症筛查测试的获取和完成的计划， 并招募了一批患者导航员，以应对我们流域内影响的常见疾病 少数群体，包括肺癌、结直肠癌和乳腺癌，以帮助来自不同背景的患者 进入我们的医疗保健系统并有效地使用它。传统上，患有癌症的儿童经历了非常 儿科肿瘤学领域经常处于前沿的临床研究参与率很高 癌症临床研究。 ACC 儿科肿瘤学项目在当地和全国发挥了核心作用 通过收集和研究人类癌症，提高我们对儿童癌症生物学的理解 肿瘤标本，并通过进行临床试验和提高我们对最佳治疗的了解 在国家儿科合作组和临床研究联盟中发挥着非常显着的领导作用。