Clinical Trials Management Shared Resource

临床试验管理共享资源

• 批准号: 8557666
• 负责人: ROY A. JENSEN
• 金额: $ 7.12万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-11 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8557666
• 关键词: Accounting; Advanced Malignant Neoplasm; Area; Budgets; Businesses; Cancer Center; Cancer Center Support Grant; Clinical; Clinical Data; Clinical Investigator; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Continuing Education; Data; Development; Disease; Education; Enrollment; Ensure; Growth; Instruction; Kansas; Laboratories; Leadership; Life; Life Cycle Stages; Maintenance; Malignant Neoplasms; Manuscripts; Mentors; Modeling; Monitor; Nursing Research; Occupational activity of managing finances; Office Management; Patients; Pharmaceutical Preparations; Preparation; Procedures; Process; Protocols documentation; Quality Control; Recommendation; Regulation; Regulatory Affairs; Research; Research Activity; Research Personnel; Resource Development; Resource Sharing; Resources; Safety; Scientist; Screening procedure; Services; Site; System; Therapeutic; Time; Training; Translational Research; Universities; base; cancer care; cost effective; data management; meetings; multidisciplinary; operation; patient population; quality assurance; sound; translational clinical trial; working group

The Clinical Trials Management Shared Resource (CTMSR) is led by Raymond P. Perez, MD and provides comprehensive, centralized support services that span the life cycle of cancer clinical trials from concept through manuscript, and assures that the patient population and resources needed to successfully conduct these trials in compliance with all federal, state and local regulations are in place. A resource staff of 35.6 FTE manage a portfolio of 116 clinical protocols (19 institutional investigator-initiated, 31 industrial, and 65 from cooperative groups). The CTMSR is functionally organized into four distinct groups: (1) Study Implementation and Regulatory Compliance (11 FTE) provides project development/management and regulatory affairs functions, and administrative support for the KUCC Protocol Review and Monitoring System; (2) Research Finance (2 FTE) provides comprehensive budget development, financial management for active protocols, and research billing compliance; (3) Clinical Trials (17.6 FTE) provides research nursing, study coordination, and data management coordination; and, (4) Research Assurance (1 FTE) provides monitoring, auditing, and quality assurance/control (QA/QC) oversight of clinical research and administratively supports the KUCC Data and Safety Monitoring Committee. The CTMSR has enabled a nearly 5-fold increase in clinical trials accrual at KUCC since 2006, particularly to institutional investigator-initiated trials (IIT) that now account for almost 63% of all therapeutic enrollments. Additional operational highlights include development and improvement of standard operating procedures across the resource, particularly for financial management, where process improvements yielded a sustainable business model, and support for local and regional collaborations at multiple affiliated sites. In summary, the CTMSR has facilitated significant growth of investigator-driven clinical research at KUCC, while implementing and administering cost-effective processes to ensure that the research activities have scientific merit, protect safety, maintain scientific integrity, and are fiscally sound.

临床试验管理共享资源（CTMSR）由医学博士Raymond P. Perez领导，提供全面、集中的支持服务，涵盖癌症临床试验从概念到手稿的生命周期，并确保成功开展这些试验所需的患者人群和资源符合所有联邦、州和地方法规。一个35.6 FTE的资源工作人员管理116个临床协议的组合（19个机构制药商发起，31个工业，65个来自合作团体）。CTMSR在功能上分为四个不同的组：（1）研究实施和法规遵从性（11 FTE）提供项目开发/管理和法规事务功能，以及对KUCC方案审查和监测系统的行政支持;（2）研究财务（2 FTE）提供全面的预算开发、活动方案的财务管理和研究账单遵从性;（3）临床试验（17.6 FTE）提供研究护理，研究协调和数据管理协调;（4）研究保证（1 FTE）提供临床研究的监测，审计和质量保证/控制（QA/QC）监督，并在行政上支持KUCC数据和安全监测委员会。自2006年以来，CTMSR使KUCC的临床试验增加了近5倍，特别是机构制药商发起的试验（IIT），现在占所有治疗入组的近63%。其他业务重点包括制定和改进整个资源的标准作业程序，特别是财务管理，其中流程改进产生了可持续的业务模式，并支持多个附属地点的地方和区域合作。总而言之，CTMSR促进了KUCC制药驱动的临床研究的显著增长，同时实施和管理具有成本效益的流程，以确保研究活动具有科学价值，保护安全性，保持科学完整性，并且是可靠的。