Clinical Protocol & Data Management

临床方案

• 批准号: 8475468
• 负责人: MIRIAM B BISCHOFF
• 金额: $ 16.02万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8475468
• 关键词: Adverse event; Agreement; Awareness; Budgets; California; Cancer Center; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Database; Communities; Conduct Clinical Trials; Data; Data Collection; Data Reporting; Development; Doctor of Philosophy; Documentation; Education; Faculty; Funding; Goals; Growth; Guidelines; Industry; Institutional Review Boards; Judgment; Malignant Neoplasms; Medical Research; Monitor; Operations Research; Patient Care; Performance; Procedures; Process; Protocols documentation; Reporting; Research; 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种集中资源，为临床研究人员提供监管，财务和行政服务，以促进协议的有效激活，从而使研究人员能够专注于科学研究需求和患者护理。 资源计划有助于提高对临床试验的认识和应计的意识，并将对临床研究的质量和效率集中和标准化，以符合临床研究的质量和效率 监管，文档和监督要求。 该资源由医学博士乔治·费舍尔（George Fisher）博士和设施总监Miriam Bischoff MS（MBA）领导。他们与临床研究副总监Branimir Sikic一起，自2003年成立以来，他们一直领导该组织。执行委员会为资源设定了方向。 在过去的六年中，资源扩大了其作用和权威。它在医学院内达到了一定程度的尊重，这导致了与关键部门和IRB达成协议。这扩大了资源的作用，并导致集中化和提高癌症临床研究的效率提高。例如，所有不良事件报告现在首先将数据与安全监控委员会（DSMC）发送到实时处理和审查的资源，仅发送给 当DSMC认为根据IRB提供的准则和委员会的判决为基础，IRB认为这样做是适当的。现在，所有具有行业支持的研究都由资源预算。这导致预算制定时间下降并增加了退款。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，尤其是我们的研究人员开始的试验。我们已经采取了措施将研究业务与北加州癌症中心（NCCC）整合在一起。所有适用的NCCC研究都在OnCore临床试验数据库中。 该资源的资金已从2004年的75万美元增加到2009年的260万美元。提供了独特的服务（例如IRB提交，预算，报告的不良事件等），并已从2006年的933人增长到2008年的5,494，由于安全报告集中所致。 资源的增长已精心策划，以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企业。