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中文摘要
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OCTRI一直是OHSU的领导者,为有效和高效的单中心和多中心治疗奠定了基础。 临床试验这些正在进行的努力包括实施OHSU的电子临床研究 信息系统(eCRIS),并实施单一IRB审查模式和主合同。然而,在这方面, 在开发、测试、实施和传播最佳程序方面仍然存在许多挑战, 支持临床试验。在目前成功努力的基础上,犯罪司法所将设立审判联络处 创新中心(LTIC)。LTIC将成为新成立的临床研究办公室(OCR)的一部分, 将精简和促进研究的启动和实施,采用流程再造, 启动活动的周期时间,并增加并行进行的工作量。ocr将 为临床研究提供本地支持,并且作为LTIC,还与CTSA试验进行对接 创新中心(TIC),以加强在OHSU的临床试验操作,与区域合作伙伴和 社区,并与CTSA网络。这些努力将不断得到测试和验证,以确保其有效性, 并将与CTSA网络共享。这将最终有助于改善人类健康, 和更多的临床试验,从而产生新的治疗方法。 OCTRI有许多正在进行的计划,以识别和解决受试者入组/保留的障碍, 临床研究。其中包括调查和焦点小组;向部门主任提供反馈;设计 并通过OHSU电子健康记录实施基于信息的招聘工具 (包括最近通过Epic MyChart患者门户网站直接招募患者的随机试验); 协助实验设计和操作实施,确定资源; 经验丰富的监管和研究协调员,负责高优先级方案;与社区建立伙伴关系 医疗中心。然而,这些努力有些零散,需要扩大以满足CTSA 网络倡议。在这些持续努力的基础上,OCTRI将建立一个招聘核心, 招聘创新中心(LRICs)。该股将由经验丰富的人员组成 擅长招募和保留研究受试者,并将为研究者提供咨询,以评估 招聘的可行性,并使用经过测试和验证的方法来实施招聘, 将加强利用OHSU的EHR(Epic)进行招聘和保留的现有优势,并将发挥 与CTSA网络招聘创新中心(RIC)的联络。这些努力将继续下去。 经过测试和验证的有效性,并将与CTSA网络共享。这最终将有助于 通过更快的招募和实现招募目标来改善人类健康,这将导致新的 治疗发展
英文摘要
OCTRI has been a leader within OHSU in creating the foundation for effective and efficient single- and multicenter clinical trials. These ongoing efforts include implementation of OHSU’s electronic Clinical Research Information System (eCRIS), and implementing single IRB review models and master contracts. However, numerous challenges remain in developing, testing, implementing, and disseminating optimal procedures for supporting clinical trials. Building on ongoing successful efforts, OCTRI will create the Liaison to Trial Innovation Centers (LTICs). LTICs will be part of the newly created Office of Clinical Research (OCR), which will streamline and facilitate study start-up and implementation, employing process reengineering to decrease the cycle time for start-up activities and increase the amount of work conducted in parallel. The OCR will provide local support for clinical research studies, and, as the LTICs, also interface to the CTSA Trial Innovation Centers (TICs) to enhance clinical trials operations at OHSU, with regional partners and the community, and with the CTSA network. These efforts will be continually tested and validated for effectiveness, and will be shared with the CTSA network. This will ultimately contribute to improved human health via faster and more productive clinical trials that lead to new therapeutics. OCTRI has many ongoing initiatives to identify and address barriers to enrollment/retention of subjects into clinical research studies. These include surveys and focus groups; feedback to department directors; design and implementation of informatics-based recruitment tools through the OHSU Electronic Health Record (including a recent randomized trial of direct recruitment of patients via the Epic MyChart patient portal); assistance with experimental design and operational implementation, identification of resources; assignment of experienced regulatory and study coordinator staff to high priority protocols; and partnerships with community medical centers. However, these efforts are somewhat fragmented, and need to be expanded to meet CTSA network initiatives. Building on these continuing efforts, OCTRI will create a Recruitment Core that will function as the Liaison to Recruitment Innovation Centers (LRICs). This unit will be staffed by experienced personnel skilled in recruitment and retention of research subjects, and will provide consultation to investigators to assess recruitment feasibility and implement recruitment using tested and proven methods tailored to individual needs, will enhance current strengths in utilizing OHSU’s EHR (Epic) for recruitment and retention, and will function as the liaison with the CTSA Network Recruitment Innovation Centers (RICs). These efforts will be continually tested and validated for effectiveness, and will be shared with the CTSA network. This will ultimately contribute to improved human health via faster recruitment and attainment of enrollment goals, which will lead to new therapeutic development.
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Core-003
Admin-Core-001
Oregon Clinical and Translational Research Institute Quality Assurance and Quality Control Project
Oregon Clinical and Translational Research Institute
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