PROTOCOL-SPECIFIC RESEARCH SUPPORT

特定于协议的研究支持

• 批准号: 7944684
• 负责人: RAYMOND P PEREZ
• 金额: $ 12.8万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-21 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7944684
• 关键词: Address; Adverse event; Award; Cancer Center; Cancer Center Support Grant; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials Data Monitoring Committees; Collection; Communication; Data; Databases; Disease; Documentation; Eligibility Determination; Enrollment; Ethics; Funding; Human Resources; Informed Consent; Learning; Maintenance; Monitor; Nursing Research; Patient Participation; Patient Recruitments; Patient Schedules; Patients; Phase; Phase I Clinical Trials; Principal Investigator; Protocols documentation; Reporting; Research; Research Personnel; Research Priority; Research Project Grants; Research Support; Research Training; Resources; Safety; Testing; Visit; Work; base; computerized; experience; novel; quality assurance

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.

临床研究办公室（OCR）培训，监督和管理研究护士和数据 协调员负责临床方案。因为这些研究人员是通过 基于实际工作的退款，而不是通过对特定奖励的资助工作预留，OCR 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， 合格的患者。这种方法使癌症中心能够满足研究者的需求， 一个共同的研究支持人员，可分配给高优先级的研究，如 可行性和第一阶段协议。OCR维持研究支持人员团队， 在I期试验和特定疾病方面的集中经验，因此分配到 特定的I期方案可以反映在给定的I期方案上的登记是否限于给定的 疾病 参与方案特定研究支持的研究协调员被分配到指定的优先级 OCR的研究。所涉及的工作包括学习新的协议，确保文件的知情 知情同意、审查和确认是否符合资格标准、登记患者、协调 方案要求的测试和访视，收集和管理数据，将数据输入计算机化数据库， 为主要研究者提供中期数据总结，及时提交不良事件文件， 并向安全和数据监查委员会提供季度报告。 PSRS资源专门用于高优先级的达特茅斯导弹发射机启动的第一阶段， 可行性试验（包括新疗法的原理验证）。在最近的奖励期内，第一阶段 方案累积总计437例患者，每年平均入组84例。第一阶段的大部分 在达特茅斯研究中心发起的研究中，增加了71%，过去平均每年65例患者 五年