Protocol Specific Res. Support

协议特定研究。

• 批准号: 7771674
• 负责人: Geoffrey R Weiss
• 金额: $ 16.82万
• 依托单位: UNIVERSITY OF VIRGINIA
• 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/7771674
• 关键词: Access to Information; Address; Adverse event; Animals; Award; Cancer Center; Cancer Center Support Grant; Cancer Patient; Characteristics; Chemoprevention; Clinic; Clinical; Clinical Investigator; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Design; Collection; Computers; Consent; Correlative Study; Counseling; Databases; Diagnostic; Disease; Documentation; Eligibility Determination; Employee; Employment; Enrollment; Feasibility Studies; Funding; Future; Growth; Human; Human Resources; Information Technology; Institution; Intervention; Investigation; Investments; Judgment; Laboratories; Lead; Leadership; Left; Monitor; Nurses; Nursing Research; Patients; Performance; Phase; Phase I Clinical Trials; Protocols documentation; Reporting; Research Ethics Committees; Research Infrastructure; Research Personnel; Research Support; Resource Sharing; Resources; Review Committee; Risk; Rosa; Schedule; Specimen; Supportive care; Surveys; Telefacsimile; Telephone; Therapeutic; Therapy Clinical Trials; Time; Toxic effect; Training; Universities; University of Virginia Cancer Center; Virginia; Work; authority; clinical care; data management; design; empowered; follow-up; innovation; meetings; multidisciplinary; pre-clinical; research clinical testing

Funds are requested to partially support two research nurses who will be assigned to work on phase I and pilot/feasibility clinical trials designed and originating from the University of Virginia Cancer Center. The two nurses are employees of the UVa Cancer Center Clinical Trials Office. Their assignment to trials will be under the control of Dr. Weiss, Deputy Director for Clinical Research and Clinical Affairs. Assignment of the research nurses will follow approval of candidate protocols by the Cancer Center Protocol Review Committee and the University IRB. Using institutional funds, the Cancer Center has greatly expanded the CTO staff. Over the past year, over 60% of the patients enrolled on therapeutic trials were on UVa investigator-initiated trials. The Institution will continue to provide over $800,000 per year to support investigator initiated trials and the CCSG funds will augment that support. The Research Nurses supported under this Shared Resource shall: ¿ Each be assigned to 2 pilot/feasibility or early phase I clinical trials; ¿ Serve as an authoritative resource about assigned protocols to clinicians, patient-subjects, regulatory and oversight committees of the Cancer Center; ¿ Assist the investigator/co-investigator in assessing the eligibility of a patient-subject for protocol entry; ¿ Schedule clinical diagnostic studies for determination of patient-subject eligibility or for follow-up diagnostic studies for enrolled subjects; ¿ Counsel potential patient subjects about consent issues, study compliance, management of toxicities, and other protocol-related matters, by telephone or personal contact in clinic; ¿ Schedule initial and follow-up clinical evaluations for patient-subjects while entered on clinical trials; ¿ Assist the clinical investigator in managing and reporting protocol-related adverse events.

要求资金部分支持两名将分配在第一阶段工作的研究护士 以及来自弗吉尼亚大学癌症中心设计和起源的试验/可行性临床试验。这 两名护士是UVA癌症中心临床试验办公室的员工。他们对审判的分配将是 在Weiss博士的控制下，临床研究和临床事务副主任。分配 研究护士将遵循癌症中心议定书审查的候选协议的批准 委员会和大学IRB。使用机构资金，癌症中心大大扩展了 CTO工作人员。在过去的一年中，超过60％的热量试验患者进行了UVA 研究人员发动的试验。该机构每年将继续提供超过80万美元的支持 研究人员开始了试验，CCSG资金将增加支持。研究护士支持 在此共享资源下应： �将每个分配给2个初步/可行性或第一阶段临床试验； „是针对临床医生，患者对象，监管的权威资源 癌症中心的监督委员会； „协助研究者/共同投资者评估患者受试者进行方案进入的资格； �安排临床诊断研究以确定患者可能的资格或随访 针对入学受试者的诊断研究； �咨询有关同意问题，研究合规性，毒性管理的潜在患者受试者， 以及其他与方案有关的事项，通过诊所中的电话或个人联系； �在进行临床试验时，安排患者受试者的初始和随访临床评估； »协助临床研究者管理和报告协议相关的不良事件。