Clinical Protocol and Data Management

临床方案和数据管理

基本信息

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
项目类别：
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

项目摘要

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 是支持和监控 ACC 中进行的所有临床研究的行政中心无论干预措施或发起人的类型如何，CPDM 都会创建、指导和执行操作。 ACC 内开展所有癌症相关临床研究的政策和期望宾夕法尼亚大学。CPDM 的范围必然广泛，涵盖并实施政策。和程序、教育和培训、数据管理人员和研究护士的监督以及监督专业临床研究单位 (CRU) 是我们中心的重要组成部分，由 CPDM 负责监管。阶段和第二阶段方案审查，管理我们的集中临床试验管理系统 (Velos)，对临床试验进行监控和审核，并管理我们强制性临床的复杂活动研究审查委员会是 CPDM 的关键组成部分，包括运营部、合规部。和监测（DOCM），方案审查和监测系统（PRMS，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)、法律事务办公室以及我们的疾病和学科专业 CRU 负责。确保所有与癌症相关的人类受试者研究遵守所有联邦法规和机构政策以及我们 NCI 批准的 ACC 数据和安全监测计划 (DSMP)，以确保受试者安全 DSMC 与 CTSRMC 相互补充，但功能完全独立。对所有已激活的 CTSRMC 批准的协议具有独立监督责任，作为父级 ACC DSMP 委员会，并为监测的各个方面制定政策、标准和期望，当前资助期间的成人和儿科研究的审核和药物警戒。包括改进协议激活时间（与 2015 年相比缩短 50%）、改进数据跟踪系统、CRU 的增强运营以及 NCTN 试验的新领导者和协调员。在此资助期间，介入试验的年均应计费用总体增加了 116% 与上次相比（治疗增加 20%；非治疗性介入增加 314%）。将妇女和少数族裔纳入临床试验仍然是 ACC 的中心目标，也是我们的一部分致力于解决我们流域内少数民族和服务不足人群的癌症负担。在此资助期间的广泛努力使得 ACC 中的少数群体具有杰出的代表性临床试验和参加试验的黑人受试者的百分比增加了一倍，现在超过了在 ACC 就诊的黑人患者的百分比 ACC 支持所有年龄段的患者参与。在临床试验中，我们的 CTSRMC 不会批准将儿童或老年人排除在外的方案。我们受益于具有创新性的完全嵌入式儿科肿瘤学计划。几乎所有儿童恶性肿瘤的临床试验，其成员都是儿科国家小组的领导者。