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资源，可协助临床研究人员提供监管、财务和行政服务，以促进方案的有效激活，从而使研究人员能够专注于科学研究需求和患者护理。 该资源计划旨在提高人们对临床试验的认识和积累，并根据以下标准集中和标准化临床研究的质量和效率： 监管、文件和监督要求。 该资源由教务主任 George Fisher（医学博士、哲学博士）和设施主任 Miriam Bischoff MS、MBA 领导。自 2003 年该组织成立以来，他们与临床研究副主任、医学博士 Branimir Sikic 一起领导该组织。执行委员会负责制定该资源的方向。 在过去六年中，该资源扩大了其作用和权威。它在医学院内部获得了一定程度的尊重，并与关键部门和 IRB 达成协议。这扩大了资源的作用，提高了癌症临床研究的集中度并提高了效率。例如，所有不良事件报告现在首先发送到资源，由数据和安全监测委员会 (DSMC) 进行实时处理和审查，并且仅发送到 当 DSMC 根据 IRB 提供的指导方针和委员会的判断认为适当时，IRB 会这样做。现在，所有获得行业支持的研究均由该资源制定预算。这导致了预算制定时间的减少和退款的增加。已经制定和部署了新的标准操作程序和培训计划，以提高研究质量，特别是我们的研究者发起的试验。我们已采取措施将研究业务与北加州癌症中心 (NCCC) 整合。所有适用的 NCCC 研究均位于 OnCore 临床试验数据库中。 该资源的资金从 2004 年的 75 万美元增加到 2009 年的 260 万美元。对所提供的独特服务（例如 IRB 提交、制定的预算、报告的不良事件等）进行跟踪，并从 2006 年的 933 项增加到 2008 年的 5,494 项，其中大部分增加是由于安全报告的集中化。 资源的增长是为了提高效率和研究质量而精心策划的。我们将继续调整资源的组织和服务来支持我们的临床研究事业。