PROTOCOL REVIEW AND MONITORING SYSTEM (Core-010)

协议审查和监测系统 摘要 方案审查和监测系统(PRMS)对于亨斯迈癌症研究所(HCI)的目标至关重要 为我们的患者维护充满活力的临床研究组合，包括科学上优秀的临床试验；支持 我们教员的临床研究努力；以及改进癌症检测、诊断、治疗和治疗的策略 通过我们的临床研究活动进行预防。人机界面的PRMS功能是由临床癌症实现的 调查委员会(CCIC)。HCI强大的CCIC使我们能够审查建议的 临床研究，评估拟议方案对我们癌症中心战略目标的贡献，以及 评估正在进行的研究的科学进展。 CCIC 1)对在HCI进行的所有与癌症相关的研究进行彻底的科学审查，2) 确定研究协议的优先顺序并防止协议竞争，3)确定访问HCI的协议的优先顺序 临床试验办公室支持，4)评估持续进展以实现应计目标的正在进行的方案，5) 审查和批准方案修正案，以及6)结束累积不足试验。在一项研究可以 提交给CCIC，必须提交给适当的多学科疾病小组(MDG) 由该领域的HCI医生社区进行审查、批准和优先评级。 在本报告所述期间，为支持HCI对临床研究的机构承诺，HCI 实施了机构礼仪开发委员会(IPDC)，以帮助高质量的发展 调查员发起的试验和两个阶段的审查程序，以促进严格和有效地批准 学习。在第一阶段审查中，试验由可行性行政审查委员会(FAR)进行评估， 它包括临床方案和数据管理/临床试验的行政领导 办公室。FAR委员会评估预算(充足资金)、监管、人事支持等方面的研究 (临床研究协调员和研究数据协调员)、应计目标、首席研究员(PI)和 千年发展目标绩效考核，完成绩效指标要求的培训。FAR委员会的初步审查确保 提交CCIC第二阶段审查的研究是强有力的，所有行政问题都得到了解决。 在第二阶段，在肿瘤学方面拥有广泛和广泛专业知识的CCIC委员会审查 新的临床方案的科学价值和评估开放研究的进展。CCIC委员会包括 来自内科肿瘤学、外科肿瘤学、儿科血液肿瘤学、放射肿瘤学、 生物统计学、药理学、病理学、基础科学、人口科学、研究护理学以及 患者权益倡导者和HCI的首席执行官/主任Mary Beckerle博士，作为当然成员。

PROTOCOL REVIEW AND MONITORING SYSTEM ABSTRACT The Protocol Review and Monitoring System (PRMS) is critical to Huntsman Cancer Institute's (HCI) goal to maintain a vibrant clinical research portfolio of scientifically excellent clinical trials for our patients; support the clinical research efforts of our faculty; and improve strategies for cancer detection, diagnosis, treatment, and prevention through our clinical research activities. PRMS functions at HCI are fulfilled by the Clinical Cancer Investigations Committee (CCIC). HCI's robust CCIC enables us to review the scientific merit of proposed clinical studies, evaluate the contribution of proposed protocols to the strategic aims of our Cancer Center, and assess the scientific progress of ongoing studies. The CCIC 1) conducts thorough scientific review of all cancer-related studies performed at HCI, 2) prioritizes research protocols and prevents protocol competition, 3) prioritizes protocols for access to HCI Clinical Trials Office support, 4) evaluates ongoing protocols for continued progress toward accrual goals, 5) reviews and approves protocol amendments, and 6) closes under-accruing trials. Before a study can be presented to the CCIC, it must be submitted to the appropriate Multidisciplinary Disease Group (MDG) for review, approval, and priority rating by the community of HCI physicians in that area. To support HCI's institutional commitment to clinical research, in the current reporting period HCI implemented a Institutional Protocol Development Committee (IPDC) to aid in the development of high quality investigator-intitated trials and a two-stage review process to facilitate rigorous and efficient approval of studies. In stage one review, trials are evaluated by the Feasibility Administrative Review (FAR) committee, which comprises the administrative leadership of the Clinical Protocol and Data Management/Clinical Trials Office. The FAR committee evaluates studies for budget (adequate funding), regulatory, personnel support (clinical research coordinators and research data coordinators), accrual goals, principal investigator (PI) and MDG accrual performance, and completed PI required trainings. Initial review by the FAR committee ensures that studies submitted for stage two CCIC review are strong, with all administrative concerns resolved. In stage two, the CCIC committee, which has broad and extensive expertise in oncology, reviews the scientific merit of new clinical protocols and assesses progress of open studies. The CCIC committee includes representatives from medical oncology, surgical oncology, pediatric hematology-oncology, radiation oncology, biostatistics, pharmacology, pathology, basic science, population sciences, and research nursing, as well as a patient advocate and HCI's CEO/Director Mary Beckerle, PhD, as an ex-officio member.