PRMS

PRMS

• 批准号: 8306973
• 负责人: DENNIS CARSON
• 金额: $ 17.85万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8306973
• 关键词: Adverse event; Cancer Center; Cancer Center Support Grant; Cancer Therapy Evaluation Program; Charge; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Data; Disease; Ensure; Evaluation; Fostering; Goals; Grant; Healthcare Systems; Institution; Institutional Review Boards; Malignant Neoplasms; Monitor; Monitoring Clinical Trials; National Cancer Institute; Patients; Pediatric Hospitals; Peer Review; Procedures; Protocols documentation; Rebecca and John Moores UCSD Cancer Center; Reporting; Research; Resources; Review Committee; Safety; Specific qualifier value; System; Time; Translational Research; United States Department of Veterans Affairs; United States National Institutes of Health; Veterans; anticancer research; authority; cancer research center director; medical schools; meetings; member; multidisciplinary; research study

Protocol Review Monitoring System The goal of the Protocol Review and Monitoring System (PRMS) is to promote the conduct of scientifically meritorious clinical research under the aegis of the UCSD Cancer Center. The mechanism for accomplishing this is the establishment of a Protocol Review and Monitoring Committee (PRMC). The PRMC is a multidisciplinary standing committee of the Moores Cancer Center. Its charge is the scientific peer review of research studies involving patients with cancer that are conducted at UCSD or its affiliate institutions, the Veterans Administration Healthcare System San Diego and Children's Hospital San Diego. To provide this oversight function, the PRMC has the following Specific Objectives: (1) perform scientific peer review of cancer-related clinical and translational research protocols to be conducted at UCSD and affiliate institutions; (2) approve a priority designation for new cancer clinical protocols in coordination with leaders of the Cancer Center's disease-focused Specialized Cancer Units; (3) review the scientific progress of active clinical protocols through annual evaluation of subject accrual data; and (4) review in real-time those serious and unexpected adverse events that meet criteria for reporting to the UCSD Institutional Review Board (IRB). The PRMC is granted authority by the Cancer Center Director to approve the initiation and continuation of clinical cancer research protocols, or to recommend their termination according to defined review and monitoring criteria. In concert with these scientific review and monitoring functions, the PRMC directly informs the UCSD IRB of relevant scientific and subject safety issues for complementary review by that committee of cancer-related research submitted for activation at UCSD and affiliate institutions. Both the PRMC Chair and Vice Chair are members of the UCSD IRB, and approval by PRMC is required for the activation of cancer-related research at UCSD and its affiliates. In achieving its scientific review and monitoring objectives, the PRMC ensures that Cancer Center resources are effectively utilized to foster clinical cancer research that is of high scientific quality and importance.

协议审查监控系统 协议审查和监测系统（PRM）的目的是促进在UCSD癌症中心的宙斯盾下进行科学的临床研究的进行。实现此目的的机制是建立协议审查和监测委员会（PRMC）。 PRMC是摩尔癌中心的多学科常务委员会。它的指控是对涉及UCSD或其关联机构，退伍军人管理局医疗系统圣地亚哥和圣地亚哥儿童医院的研究研究研究的科学同行评审。提供这个 监督功能，PRMC具有以下特定目标：（1）对UCSD和会员机构进行的癌症相关临床和转化研究方案进行科学同行评估； （2）批准与癌症中心以疾病专门的癌症单位的领导人协调的新癌症临床方案的优先指定； （3）通过年度评估应计数据评估主动临床方案的科学进展； （4）实时审查那些符合UCSD机构审查委员会（IRB）的标准的严重和意外的不良事件。癌症中心主任批准了PRMC的授权，以批准临床癌症研究方案的启动和继续，或者根据定义的审查和监测标准推荐其终止。与这些科学审查和监测功能协同，PRMC直接向UCSD IRB告知了该癌症委员会的相关科学和主题安全问题，以在UCSD和分支机构机构中激活癌症相关研究委员会。 PRMC主席和副主席都是UCSD IRB的成员，PRMC的批准是在UCSD及其分支机构激活与癌症相关的研究所必需的。 PRMC在实现其科学审查和监测目标时，确保有效地利用癌症中心资源来培养具有高科学质量和重要性的临床癌症研究。