PROTOCOL-SPECIFIC RESEARCH SUPPORT

临床研究办公室(OCR)培训、监督和管理研究护士和数据 分配给临床方案的协调员。因为这些研究人员是通过 OCR基于实际工作的按存储容量使用计费，而不是通过为特定奖项提供资金来保留 可以分配(和重新分配)研究支持人员，以反映当前的研究重点、研究和 符合条件的患者。这一方法使癌症中心能够满足研究人员访问 一个共同的研究支助人员，可被分配到高优先级研究，如发起的调查 可行性和第一阶段协议。OCR通过以下方式维护研究支持人员团队 集中在I期试验和特定疾病方面的经验，因此分配到 特定阶段I协议可以反映在给定阶段I协议上的登记是否被限制到给定的 疾病。 参与特定协议研究支持的研究协调员被分配到指定的优先级 由OCR进行的研究。所处理的工作包括学习新的协议，确保记录知情的 同意、审查和确认符合资格标准、登记患者、协调 协议要求的测试和访问，收集和管理数据，将数据输入计算机化的数据库， 为主要研究人员提供临时数据汇总，及时提交不良事件文件， 并向安全和数据监测委员会提供季度报告。 PSR资源专门针对高优先级达特茅斯调查员发起的第一阶段和 可行性试验(包括新疗法的原则证明)。在最近的授权期内，第一阶段 协议应计总人数为437名患者，每年平均有84名患者参加。第一阶段的大部分时间 应计(71%)是达特茅斯大学研究员发起的研究，在过去平均每年有65名患者 五年了。

The Office of Clinical Research (OCR) trains, supervises, and manages research nurses and data coordinators assigned to clinical protocols. Because these research personnel are supported through chargebacks based on actual work, rather than reserved through funded effort on specific awards, the OCR can allocate (and re-allocate) research support personnel to reflect current research priorities, studies, and eligible patients. This approach allows the Cancer Center to address the needs of investigators for access to a common research support personnel available for assignment to high-priority studies, such as investigatorinitiated feasibility and Phase I protocols. The OCR maintains teams of research support personnel with focused experience in both Phase I trials and in specific diseases, so that the personnel assigned to a specific Phase I protocol can reflect whether enrollment on a given Phase I protocol is restricted to a given disease. Research coordinators involved in Protocol-Specific Research Support are assigned to designated priority studies by the OCR. Work addressed includes learning new protocols, assuring documentation of informed consent, reviewing and confirming compliance with eligibility criteria, registering patients, coordinating protocol-required tests and visits, collecting and managing data, entering data into a computerized database, providing interim data summaries for the principal investigator, submitting timely adverse event documents, and providing quarterly reports to the Safety and Data Monitoring Committee. PSRS resources are specifically targeted to high-priority Dartmouth investigator-initiated phase I and feasibility trials (including proof-of-principle for novel therapies). In the most recent award period, Phase I protocol accrual totaled 437 patients, an annual average of 84 enrollments per year. The majority of Phase I accrual (71 %) was on Dartmouth investigator-initiated studies, averaging 65 patients per year over the past five years.