Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 9075064
• 负责人: Harry Paul Erba
• 金额: $ 14.66万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 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/9075064
• 关键词: Basic Science; Biometry; Cancer Center; Cancer Control; Clinical Research; Clinical Trials; Clinical trial protocol document; Comprehensive Cancer Center; Diagnosis; Discipline; Disease; Ensure; Evaluation; Feedback; Funding; Goals; Grant; Guidelines; Institutional Review Boards; Intervention Studies; Intervention Trial; Investigation; Knowledge; Laboratory Research; Letters; Malignant Neoplasms; Minor; Mission; Modification; Monitor; Nursing Research; Patients; Prevention; Process; Protocols documentation; Radiology Specialty; Recommendation; Research; Research Infrastructure; Research Priority; Review Committee; System; Therapeutic; Work; Writing; abstracting; authority; cancer prevention; group support; meetings; member; oncology; operation; probation; survivorship; working group

PROTOCOL REVIEW AND MONITORING SYSTEM (PRMS) ABSTRACT The objective of the Protocol Review and Monitoring System (PRMS) of the UAB CCC is to assure that the interventional (therapeutic and non-therapeutic) protocols for cancer have scientific merit, that they meet the priorities of the UAB CCC, and that they progress to scientifically meaningful results. The PRMS is made up of the Disease Working Groups (DWG), the Protocol Review Committee (PRC) and the Clinical Trial Operations Committee (CTOC). The PRMS's responsibilities include the scientific review and prioritization of all interventional protocols (clinical trials). The PRMS utilizes a three-tier review process whereby all interventional protocols are assessed by the appropriate DWG for merit and prioritization and, upon approval, are submitted to the CTOC. The CTOC reviews letters of intent for compliance with CCC priority guidelines, feasibility, and infrastructure capacity. Upon CTOC approval protocols are submitted to the PRC. The PRC then undertakes a detailed scientific review and makes final decisions for approval, approval with minor modifications, deferral for major modifications, or disapproval. The PRC is composed of Cancer Center Associate Director for Clinical Research and selected members representing expertise of the various oncology disciplines, laboratory research, basic science, cancer control/prevention, radiology, biostatistics, and research nursing. Written evaluation and recommendations of the committee accompany IRB applications on protocols approved by the PRC. The CTOC also reviews all active protocols monthly in regard to patient accrual and progress and has the authority to terminate any protocol that is not progressing. During the current funding period, the PRMS has provided initial review and/or prioritization of 318 protocols with 277 (87.1%) receiving approval (with or without minor revision) and 41 (12.9%) failing to receive approval including 36 (11.3%) receiving deferral and 5 (1.6%) receiving disapproval. Of the 36 protocols receiving deferral, 35 were granted approval on resubmission. The PRMS also provided administrative prioritization of 66 national cooperative group trials with Disease Working Group support and recommendations. Over the past funding period, the PRMS provided annual review for accrual and progress of 208 active protocols. In the 2014 review for accrual and progress, the CTOC considered 108 protocols and identified 39 underperforming trials. Of those, 27 received a 12-month approval for their action plans and 12 protocols were placed on probation. Subsequently eight of those twelve were closed to accrual. The PRMS will continue rigorous review of Cancer Center protocols for scientific quality and Cancer Center priority as well as monitoring of accrual and progress of active protocols.

协议审查和监视系统（PRMS） 抽象的 UAB CCC的协议审查和监视系统（PRM）的目的是确保 癌症的介入（治疗性和非治疗性）方案具有科学优点，他们满足 UAB CCC的优先事项，并取得了科学意义的结果。 PRM由 疾病工作组（DWG），协议审查委员会（PRC）和临床试验行动 委员会（CTOC）。 PRMS的职责包括所有人的科学审查和优先级 介入方案（临床试验）。 PRMS利用三层审查过程，所有介入 协议由适当的DWG评估以进行优异和优先级，并在批准后提交 到CTOC。 CTOC审查了遵守CCC优先级指南，可行性和 基础设施能力。 CTOC批准方案将提交给中国。中国然后承担 详细的科学审查，并做出最终决定以批准，批准，并进行了轻微的修改，延期 进行重大修改或不赞成。中国由临床癌症中心副主任组成 研究和选择的成员，代表各种肿瘤学科的专业知识，实验室 研究，基础科学，癌症控制/预防，放射学，生物统计学和研究护理。书面 委员会的评估和建议伴随IRB申请，根据协议的批准 中国CTOC还每月审查所有有关患者应计和进展方面的活动方案，并具有 终止任何不进行的协议的权力。 在当前的资金期间，PRMS提供了318个协议的初步审查和/或优先级 有277（87.1％）获得批准（有或没有次要修订）和41（12.9％）未获得批准 包括36（11.3％）接受延期和5（1.6％）接受不赞成的情况。在接收的36个协议中 在重新提交时获得了35名延期批准。 PRM还提供了行政优先级 66国家合作小组试验，具有疾病工作组的支持和建议。在 过去的资金期，PRM提供了208个主动协议的应计和进度的年度审查。在 2014年应计入和进度评论，CTOC考虑了108个协议，并确定了39个表现不佳 试验。其中27个获得了12个月的行动计划批准，并制定了12个协议 缓刑。随后，这十二个中有八个被关闭为应计。 PRM将继续严格审查 癌症中心方案的科学质量和癌症中心优先级以及监控应计和监测 活动协议的进度。