Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10330976
• 负责人: DAN TOBY VOGL
• 金额: $ 106.38万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-01-15 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10330976
• 关键词: Abbreviations; Address; Adult; Age; Black race; Cancer Burden; Cancer Center; Cancer Center Support Grant; Catchment Area; Child; Childhood; Clinical Cancer Center; Clinical Data; Clinical Investigator; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Community Outreach; Complement; Complex; Conduct Clinical Trials; Data; Discipline; Disease; Elderly; Elements; Enrollment; Ensure; Focus Groups; Funding; Goals; Hispanic; Home; Human Subject Research; Individual; Infrastructure; Institutional Policy; Intervention; Intervention Trial; Investments; Lead; Leadership; Legal; Longevity; Malignant Childhood Neoplasm; Malignant Neoplasms; Minority; Minority Enrollment; Minority Groups; Monitor; Monitoring Clinical Trials; Nursing Research; Parents; Patient Participation; Patients; Pediatric Hospitals; Pediatric Oncology; Pediatric Research; Peer Review; Pennsylvania; Philadelphia; Policies; Procedures; Protocols documentation; Regulation; Reporting; Research; Review Committee; Safety; Services; Source; Study Subject; Supervision; System; Time; Training and Education; Underserved Population; Universities; Update; Woman; Work; acronyms; base; black patient; cancer clinical trial; cancer health disparity; cancer research center director; community engagement; data integrity; data management; expectation; experience; human subject; improved; innovation; investigator-initiated trial; medical specialties; member; minority children; oncology program; operation; participant safety; pharmacovigilance; quality assurance; research study; safety study; treatment trial

PROJECT SUMMARY – CPDM, DSM, Women and Minorities, Lifespan The CPDM is the administrative home for support and monitoring of all clinical research conducted in the ACC regardless of the type of intervention or sponsor. The CPDM creates, directs and enforces the operational policies and expectations for the conduct of all cancer-related clinical research within the ACC across the University of Pennsylvania. The CPDM scope is of necessity broad, encompassing and implementing policies and procedures, education and training, supervision of data managers and research nurses, and oversight over the specialty clinical research units (CRUs) that are a vital part of our Center. The CPDM oversees first- stage and second-stage protocol review, manages our centralized clinical trials management system (Velos), performs monitoring and auditing of clinical trials, and manages the complex activities of our mandatory clinical research review committees. Key elements within the CPDM are the Department of Operations, 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 Office of Legal Affairs, along with our disease and discipline-specialized CRUs. The DSMC is responsible for ensuring that all cancer-related human subjects studies abide by all Federal regulations and institutional policies as well as our NCI-approved ACC Data and Safety Monitoring Plan (DSMP) to ensure subject safety and study integrity. The DSMC complements yet functions completely independently of CTSRMC. The DSMC has independent oversight responsibility for all activated CTSRMC-approved protocols, serves as the parent committee for the ACC DSMP, and sets policies, standards and expectations for all aspects of monitoring, auditing and pharmacovigilance for adult and pediatric studies. Key initiatives in the current funding period include improved times for protocol activation (50% shorter compared to 2015), improved data tracking systems, enhanced operations of the CRUs, and a new leader and coordinator for NCTN trials. The result overall has been a 116% increase in average annual accruals to interventional trials during this funding period compared to the last (20% increase for treatment; 314% increase in non-therapeutic interventional). Ensuring the inclusion of Women and Minorities in clinical trials continues to be a central goal for the ACC, part of our commitment to address the cancer burden in minority and underserved populations in our catchment area. Extensive efforts during this funding period have resulted in exceptional representation of minorities on ACC clinical trials and doubling of the percentages of Black subjects enrolled on trials, now exceeding the percentage of Black patients seen at the ACC. Lifespan. The ACC supports participation of patients of all ages in clinical trials. Our CTSRMC will not approve protocols that exclude children or the elderly without a compelling rationale. We benefit from a fully embedded Pediatric Oncology Program that performs innovative clinical trials for nearly all childhood malignancies, with members who lead the pediatric National Group.

项目摘要 - CPDM，DSM，妇女和少数民族，寿命 CPDM是支持和监测ACC中所有临床研究的行政家园 不管干预或赞助商的类型。 CPDM创建，指导和执行操作 对ACC中所有与癌症有关的临床研究进行的政策和期望 宾夕法尼亚大学。 CPDM范围必须广泛，包括和实施政策 以及程序，教育和培训，数据经理和研究护士的监督以及监督 在专业临床研究单元（CRU）上，这是我们中心的重要组成部分。 CPDM首先监督 阶段和第二阶段协议审查，管理我们的集中临床试验管理系统（VELOS）， 对临床试验进行监测和审核，并管理我们强制性临床的复杂活动 研究审查委员会。 CPDM内的关键要素是运营部，合规部 和监视（DOCM），协议审查和监视系统（PRMS，称为临床试验 科学审查和监测委员会[CTSRMC]），数据与安全监测委员会（DSMC）， 和法律事务办公室，以及我们的疾病和纪律特有的CRU。 DSMC负责 确保所有与癌症有关的人类学科研究都遵守所有联邦法规和机构 政策以及我们的NCI批准的ACC数据和安全监控计划（DSMP），以确保主题安全 并研究完整性。 DSMC完全独立于CTSRMC完成功能。 DSMC 对所有激活CTSRMC批准的协议都具有独立的监督责任，作为父母 ACC DSMP委员会，并为监测的各个方面设定政策，标准和期望， 成人和小儿研究的审计和药物养护。当前资金期间的关键倡议 包括提高协议激活的时间（比2015年短50％），改进的数据跟踪 系统，CRUS的增强操作以及NCTN试验的新领导者和协调员。结果 总体而言，在此资助期间，平均年度准确性增长了116％ 与最后一次相比（治疗增加了20％；非治疗性介入的314％）。确保 将妇女和少数民族纳入临床试验一直是ACC的核心目标，这是我们的一部分 致力于解决我们集水区少数群体和服务不足的人群中癌症烧伤的承诺。 在此资助期间的广泛努力导致了少数民族对ACC的特殊代表 临床试验和参加试验的黑人受试者百分比的两倍，现在超过 在ACC中看到的黑人患者百分比。寿命。 ACC支持所有年龄段患者的参与 在临床试验中。我们的CTSRMC不会批准不包括儿童或较早的协议 引人入胜的理由。我们受益于一项完全嵌入的儿科肿瘤学计划，该计划执行创新 几乎所有童年时期的尼尔尼奇（Malignancys）的临床试验，领导儿科国家组的成员。