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。 该资源的计划有助于提高对临床试验的认识和应计费用，以及集中和标准化按照以下要求进行临床研究的质量和效率： 法规、文件和监督要求。 该资源是由教师主任，乔治费舍尔，医学博士，博士和设施主任，米里亚姆比肖夫MS，MBA领导。他们，沿着Branimir Sikic，医学博士，副主任，临床研究，领导这个组织自2003年成立以来。执行委员会确定资源的方向。 在过去六年中，该资源扩大了其作用和权威。它在医学院内获得了一定程度的尊重，并与关键部门和IRB达成了协议。这扩大了资源的作用，并导致癌症临床研究的集中化和效率提高。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提供的指南和委员会的判断认为适当时，IRB。所有得到行业支持的研究现在都由资源预算。这导致编制预算的时间减少，费用退回增加。新的标准操作程序和培训计划已经开发和部署，以提高研究质量，特别是我们的研究者发起的试验。我们已经采取措施将研究工作与北方加州癌症中心（NCCC）整合起来。所有适用的NCCC研究都在OnCore临床试验数据库中。 该资源的供资从2004年的750 000美元增加到2009年的260万美元。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）2006年的933起增加到2008年的5，494起，其中大部分增加是由于安全报告集中。 资源的增长是为了提高效率和研究质量。我们将继续调整资源的组织和服务，以支持我们的临床研究事业。