Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 9905365
• 负责人: Timothy Steven Olson
• 金额: $ 11.2万
• 依托单位: EMORY UNIVERSITY
• 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/9905365
• 关键词: Address; Attention; Bioethics Consultants; Bioinformatics Shared Resource; Biometry; Calendar; Cancer Center Support Grant; Charge; Chest; Clinical; Clinical Research; Clinical Research Protocols; Clinical Trials; Clinical Trials Network; Committee Members; Conflict (Psychology); Consultations; Data; Disease; Doctor of Philosophy; Eligibility Determination; Enrollment; Ensure; Feedback; Fostering; Frequencies; Gender Role; Goals; Guidelines; Institutes; Institutional Review Boards; Investigational Therapies; Malignant Neoplasms; Medical Oncologist; Mission; Monitor; National Clinical Trials Network; Patients; Pediatric Oncologist; Performance; Protocols documentation; Reporting; Research; Research Activity; Research Personnel; Research Proposals; Review Committee; Risk; Safety; Science; Site; Suggestion; Surveys; System; Time; anticancer research; authority; base; cancer clinical trial; design; expedited review; interest; meetings; member; next generation; programs; response; treatment trial; working group; Address; Attention; Bioethics Consultants; Bioinformatics Shared Resource; Biometry; Calendar; Cancer Center Support Grant; Charge; Chest; Clinical; Clinical Research; Clinical Research Protocols; Clinical Trials; Clinical Trials Network; Committee Members; Conflict (Psychology); Consultations; Data; Disease; Doctor of Philosophy; Eligibility Determination; Enrollment; Ensure; Feedback; Fostering; Frequencies; Gender Role; Goals; Guidelines; Institutes; Institutional Review Boards; Investigational Therapies; Malignant Neoplasms; Medical Oncologist; Mission; Monitor; National Clinical Trials Network; Patients; Pediatric Oncologist; Performance; Protocols documentation; Reporting; Research; Research Activity; Research Personnel; Research Proposals; Review Committee; Risk; Safety; Science; Site; Suggestion; Surveys; System; Time; anticancer research; authority; base; cancer clinical trial; design; expedited review; interest; meetings; member; next generation; programs; response; treatment trial; working group

PROTOCOL REVIEW AND MONITORING SYSTEM PROJECT SUMMARY/ ABSTRACT The Protocol Review and Monitoring System (PRMS), administered by Winship’s Clinical and Translational Review Committee (CTRC), is responsible for the review and approval of all cancer clinical trials proposed by Winship members for scientific quality and merit. The CTRC is charged with the responsibility to prioritize, monitor, and terminate clinical trials based on ongoing scientific validity, feasibility, overall progress, and patient accrual. CTRC’s overarching goal is to support and facilitate the conduct of Winship’s clinical cancer research efforts. To fulfil this goal, CTRC addresses the following set of objectives using clearly-defined criteria and mechanisms to: (1) review new clinical research proposals for scientific rationale, appropriate design, and feasibility; (2) prioritize clinical research proposals using uniform and objective metrics in consultation with Winship’s cancer disease-site working groups and with Winship’s research programs to ensure alignment with Winship’s overall strategic objectives; (3) review and monitor the progress of active clinical studies for accrual and scientific validity, and to terminate protocols which are not meeting accrual targets and/or where new scientific evidence renders the study irrelevant; (4) determine and assign level of potential risk to patients enrolled on study that will inform the rigor and frequency of review by Winship’s Data Safety Monitoring Committee (DSMC); and (5) provide a platform for educating the next generation of clinical researchers on the best practices in the design and conduct of cancer clinical trials. The CTRC functions as a distinct, independent body from the Winship Clinical Trials Office (CTO) and the DSMC. Significant changes instituted to enhance the function of the CTRC in response to suggestions emanating from the last CCSG competitive renewal include: (1) enactment of review guidelines to assess the ability of new studies to meet accrual targets, with special attention to potential eligibility conflict with ongoing clinical trials; (2) adding a requirement that new study proposals address scientific questions relevant to Winship’s overall mission and objectives of its research programs; (3) adding a requirement for institutional (investigator-initiated) proposals to undergo biostatistics review prior to submission for CTRC review and to include a co-investigator from Winship’s Biostatistics and Bioinformatics Shared Resource (BBISR); (4) requiring a risk level determination at the time of scientific review for all treatment trials; (5) instituting a regular biennial survey of Winship members to obtain feedback on CTRC function and value added to Winship’s clinical research activities; and (6) recognizing outstanding CTRC members (excluding co-chairs) based on specific metrics including meeting attendance and protocol review.

协议审查和监视系统 项目摘要/摘要 由Winship的临床和翻译管理的协议审查和监控系统（PRMS） 审查委员会（CTRC）负责审查和批准所有提议的癌症临床试验 Winship成员的科学质量和功绩。 CTRC负责优先级的责任 根据持续的科学有效性，可行性，整体进步和患者，监测并终止临床试验 应计。 CTRC的总体目标是支持和促进Winship的临床癌症研究 努力。为了实现此目标，CTRC使用明确定义的标准解决以下目标集 机制：（1）审查有关科学原理，适当设计和的新临床研究建议 可行性; （2）优先使用统一和客观指标协商的临床研究建议 Winship的癌症疾病现场工作组以及Winship的研究计划，以确保与 Winship的整体战略目标； （3）审查和监视赚取的主动临床研究的进度 和科学有效性，并终止不符合核对目标和/或新的方案 科学证据使研究无关； （4）确定并为入学的患者确定潜在风险水平 在研究中，将为Winship的数据安全监测委员会提供严格和审查的频率 （DSMC）; （5）提供了一个平台，以教育下一代临床研究人员有关最佳实践的平台 在癌症临床试验的设计和行为中。 CTRC作为与独立的独立机构的作用 Winship临床试验办公室（CTO）和DSMC。进行了重大变化，以增强 CTRC响应于最后一次CCSG竞争续订提出的建议，包括：（1）制定 审查指南，以评估新研究达到目标目标的能力，并特别注意潜在 资格与正在进行的临床试验发生冲突； （2）补充要求新的研究提案解决科学的要求 与Winship有关其研究计划的整体使命和目标有关的问题； （3）添加要求 用于机构（调查员发起的）建议，以在提交CTRC之前进行生物统计学审查 审查并包括Winship的生物统计学和生物信息学共享资源的共同研究者 （BBISR）; （4）在所有治疗试验的科学审查时需要确定风险水平； （5）建立 定期对Winship成员进行的每两年一次调查，以获取有关CTRC功能的反馈，并添加了值 Winship的临床研究活动； （6）认可出色的CTRC成员（不包括联合主席） 基于特定指标，包括会议和协议审查。