PROTOCOL REVIEW AND MONITORING SYSTEM (Core-010)

方案审查和监测系统 摘要 方案审查和监测系统（PRMS）对亨斯迈癌症研究所（HCI）的目标至关重要， 保持一个充满活力的临床研究组合的科学优秀的临床试验为我们的病人;支持 我们的教师的临床研究工作;并改善癌症检测，诊断，治疗和 通过我们的临床研究活动进行预防。HCI的PRMS功能由临床癌症 调查委员会。HCI强大的CCIC使我们能够审查拟议的 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HCI进行的所有癌症相关研究进行全面的科学审查，2） 优先研究协议并防止协议竞争，3）优先访问HCI的协议 临床试验办公室支持，4）评估正在进行的方案，以继续实现应计目标，5） 审查和批准方案修订，以及6）关闭累积试验。在一项研究能够 提交给CCIC，必须提交给适当的多学科疾病组（MDG）， 审查，批准，并由该地区的HCI医生社区的优先级评级。 为了支持HCI对临床研究的机构承诺，在本报告期内，HCI 成立了机构规程制定委员会（IPDC）， 由检察官发起的审判和两阶段审查程序，以促进严格和有效地批准 问题研究在第一阶段审查中，试验由可行性行政审查委员会（FAR）进行评估， 包括临床方案和数据管理/临床试验的行政领导 办公室FAR委员会评估研究的预算（充足的资金），监管，人员支持 （临床研究协调员和研究数据协调员）、应计目标、主要研究者（PI）和 千年发展目标应计业绩，并完成PI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报告是强有力的，所有行政问题都得到了解决。 在第二阶段，CCIC委员会在肿瘤学方面拥有广泛而广泛的专业知识， 新临床方案的科学价值，并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，人口科学和研究护理，以及 病人倡导者和HCI的首席执行官/主任玛丽贝克尔博士，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.