Clinical Protocol & Data Management

临床方案

• 批准号: 8181136
• 负责人: MIRIAM B BISCHOFF
• 金额: $ 19.71万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-15 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8181136
• 关键词: Adverse event; Agreement; Awareness; Budgets; California; Cancer Center; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Database; Communities; Conduct Clinical Trials; Data; Data Collection; Development; Doctor of Philosophy; Documentation; Education; Faculty; Funding; Goals; Growth; Guidelines; Industry; Judgment; Malignant Neoplasms; Medical Research; Monitor; Operations Research; Patient Care; Performance; Procedures; Process; Protocols documentation; Reporting; Research; Research Ethics Committees; Research Personnel; Research Support; Resource Sharing; Resources; Role; Safety; Services; Time; Training Programs; Translational Research; Universities; anticancer research; authority; base; data management; improved; interdisciplinary collaboration; medical schools; outreach; programs; quality assurance

The Clinical Protocol and Data Management Shared Resource provides a centralized resource that assists clinical researchers with regulatory, financial and administrative services in order to facilitate efficient activation of protocols thus allowing the researcher to focus on scientific research needs and patient care. Programs of the resource serve to increase awareness of and accrual to clinical trials, as well as to centralize and standardize the quality and efficiencies of conducting clinical research in compliance with the regulatory, documentation and oversight requirements. The resource is led by Faculty Director, George Fisher, MD, PhD, and the Facility Director, Miriam Bischoff MS, MBA. They, along with Branimir Sikic, MD, Associate Director, Clinical Research, have led this organization since its inception in 2003. An Executive Committee sets the direction for the resource. Over the past six years the resource has expanded its role and authority. It has achieved a level of respect within the School of Medicine that has led to agreements with key departments and the IRB. This has expanded the resource's role, and resulted in increased centralization and improved efficiencies for cancer clinical research. For example, all adverse event reports are now sent first to the resource for real-time processing and review by the Data and Safety Monitoring Committee (DSMC), and only sent to the IRB when the DSMC deems it appropriate to do so based upon guidelines provided by the IRB and the committee's judgment. All studies with industry support are now budgeted by the resource. This has resulted in decreased time in budget development and increased chargebacks. New standard operating procedures and training programs have been developed and deployed to improve research quality, especially of our investigator initiated trials. We have taken steps to integrate research operations with the Northern California Cancer Center (NCCC). All applicable NCCC studies are in the OnCore clinical trials database. Funding for the resource has increased from $750,000 in 2004, to $2.6 million in 2009. Unique services provided (eg IRB submissions, budgets developed, adverse events reported, etc.) are tracked, and have grown from 933 in 2006, to 5,494 in 2008, with the bulk of the increase due to safety report centralization. The growth of the resource has been orchestrated to improve efficiencies and research quality. We will continue to adjust the resource's organization and services to support our clinical research enterprise.

临床方案和数据管理共享资源提供了一个集中的资源，帮助临床研究人员提供监管、财务和行政服务，以促进有效的方案激活，从而使研究人员能够专注于科研需求和患者护理。资源项目旨在提高人们对临床试验的认识和积累，以及集中和规范临床研究的质量和效率