Clinical Protocol & Data Management

临床方案和数据管理共享资源提供一个集中的资源，为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研需求和患者护理。该资源的计划有助于提高对临床试验的认识和收益，并按照以下要求集中和标准化进行临床研究的质量和效率 监管、文件和监督要求。 该资源由学院主任，乔治·费舍尔，医学博士，和设施主任，Miriam Bischoff，MS，MBA领导。他们与Branimir Sikic医学博士，临床研究副主任一起，自2003年该组织成立以来一直领导该组织。执行委员会为资源确定方向。 在过去六年中，该资源扩大了其作用和权威。它在医学院内得到了一定程度的尊重，导致与关键部门和IRB达成了协议。这扩大了资源的作用，并提高了癌症临床研究的集中度和效率。例如，所有不良事件报告现在都首先发送到资源，由数据和安全监控委员会(DSMC)进行实时处理和审查，并且只发送到 内部审查委员会根据内部审查委员会提供的指导方针和委员会的判断，认为这样做是适当的。所有有行业支持的研究现在都按资源编制预算。这减少了预算编制的时间，增加了按存储容量使用计费。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，特别是我们的研究人员发起的试验的质量。我们已经采取措施，将研究业务与北加州癌症中心(NCCC)整合。所有适用的NCCC研究都在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。提供独特的服务(如提交IRB、制定预算、报告不良事件等)被跟踪的数据从2006年的933份增加到2008年的5 494份，其中大部分增加是由于集中了安全报告。资源的增长经过精心安排，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。

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.