CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

核心——方案审查和监控系统

• 批准号: 6102674
• 负责人: GEOFFREY R WEISS
• 金额: $ 13.16万
• 依托单位: CTRC RESEARCH FOUNDATION
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-08-06 至 1999-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6102674
• 关键词: biomedical facility; clinical research; health science research analysis /evaluation

Description: The Protocol Review and Monitoring System is managed by Dr. Geoffrey Weiss, Chairman, and Ms. Yolanda Medina, protocol specialist. The PRMS is also composed of 14 individuals who are representatives from the major oncologic treatment disciplines (medical, radiation, surgical, urologic and pediatric oncology), biostatistics, and representatives from support disciplines (nursing and pharmacy). Additional members are called upon ad hoc for particular expertise. Membership on the PRMS is rotated with the membership duration being at least three years. Five clinical facilities are affiliated With SACI (CTRC, University Hospital, VA Hospital, St. Luke's Baptist Hospital).All protocols conducted in the affiliates must receive approval through the IRB of UTHSCSA, and requirements of clinical affiliation with SACI include recognition of the authority of the PRMS and prohibition of the conduct at the affiliated instructions of cancer-related clinical protocols that have not been approved by the PRMS. PRMS reviews and stipulations are submitted to the Director of the research committee of each affiliated institution. All protocols must have the signature of the Chair of the clinical department of the Medical Schools whose member is Principal Investigator. The Chair signature endorses the requirement that the investigator mut submit the protocol to PRMS review. Cooperative group protocols are given expedited PRMS review while all other cancer-related clinical research protocols must submit to the full detailed scientific review of the PRMS. Protocols submitted for review are cancer-related therapeutic research studies that are conducted at any affiliate or seek access to SACI-shared resources. Protocols defined for submission are determined by the PRMS office based on the Principal Investigator having been identified by voluntary submission, monthly review of IRB computer files, review of cooperative mailings, a telephone call to the cooperative group member institution office, or by calls to the established protocol office coordinators for the major oncologic disciplines of the SACI-affiliated institutions. PRMS meets monthly and the goal is that PRMS review will occur prior to full IRB approval such that PRMS review will be available in time for revisions to be submitted at the time of IRB full review. The IRB review utilizes PRMS review findings in its deliberations and PRMS reviews are often pivotal in influencing IRB decisions. At the time of PRMS review, each protocol is assigned a primary and secondary reviewer and is reviewed for scientific rationale, appropriate study design, patient accrual estimate, biostatistical rationale and an estimate of the time to completion. Protocols reviewed may either be fully approved, approved following satisfactory response to stipulations, tabled or unconditionally rejected. When the protocol is approved, a schedule is set for review by the committee on protocol accrual. Investigators must submit an annual report an a final report within three months of study conclusion summarizing progress of the study. Investigators are also required to submit demographic information on protocol entries. The PRMS is empowered to terminate protocols in the event that the investigator fails to adequately comply with committee requirements, failure to satisfactorily comply with guidelines for appropriate use of shared resource or achievement of accrual goals. The PRMS sets comprehensive institutional prioritization of all protocols and requests clarification of conflicts. The PRMS has established a prioritization scheme for protocol activation and access to shared resources that places institutional investigator-initiated protocols as first priority with cooperative group studies and pharmaceutical sponsored studies, second and third, respectively.

描述：方案审查和监测系统由Dr. 主席Geoffrey韦斯和礼宾专家Yolanda Medina女士的 PRMS还由14名个人组成，他们是 主要的肿瘤治疗学科（内科，放射，外科， 泌尿科和儿科肿瘤学），生物统计学，以及来自 支持学科（护理和药学）。其他成员被称为 专门为特定的专业知识。PRMS的成员是轮流的 成员资格至少为三年。五项临床 设施隶属于SACI（CTRC，大学医院，弗吉尼亚州 医院，圣卢克浸信会医院）。 附属机构必须通过UTHSCSA的IRB获得批准， 与SACI临床联系的要求包括承认 第一百零六条当事人的诉讼请求，应当提交人民法院。 癌症相关临床方案的说明， 经PRMS批准。PRMS审查和规定提交给 各所属机构研究委员会主任。所有 方案必须有临床科室主任的签名 其成员为主要研究者的医学院。主席 签名认可研究者不得提交 PRMS审查方案。 合作组协议得到快速PRMS审查，而所有 其他癌症相关的临床研究方案必须提交完整的 对PRMS进行详细的科学审查。提交审查的方案为 癌症相关的治疗研究，在任何 附属或寻求访问SACI共享资源。协议定义用于 提交由PRMS办公室根据委托人 每月通过自愿提交确定研究者 审查IRB计算机文件，审查合作邮件，电话 致电合作团体成员机构办公室，或致电 已设立的礼宾办公室协调员， SACI附属机构的学科。PRMS每月举行会议， 目标是在IRB完全批准之前进行PRMS审查， PRMS审查将及时提供，以便提交修订 在IRB全面审查时。IRB审查采用PRMS审查 其审议和PRMS审查的结果往往是关键， 影响IRB的决定。在PRMS审查时， 指定一名主要和次要审查员，并进行科学审查 依据、适当的研究设计、患者招募估计， 生物统计学原理和完成时间的估计。 经审查的方案可以完全批准，也可以在以下情况下批准 对条款的满意答复，提交或无条件 拒绝 当方案获得批准时，将制定一个时间表，供 礼宾权责发生制委员会。调查人员必须提交年度报告 在研究结束后三个月内提交一份总结报告， 研究的进展。调查人员还必须提交 关于方案条目的人口统计信息。PRMS被授权 如果研究者未能充分 遵守委员会的要求，未能令人满意地遵守 适当使用共享资源或实现 应计目标。PRMS确定了以下方面的全面机构优先事项： 所有协议并要求澄清冲突。PRMS具有 建立了协议激活和访问的优先级方案， 共享资源， 将议定书作为合作小组研究的第一优先事项， 制药公司赞助的研究，分别为第二和第三。