CORE--PROTOCOL REVIEW AND MONITORING SYSTEM

描述：协议审查和监测系统由Dr。 主席杰弗里·韦斯和礼宾专家约兰达·梅迪纳女士。这个 临时区议会亦由14名人士组成，他们是 主要肿瘤学治疗学科(内科、放射科、外科、 泌尿学和儿科肿瘤学)，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 对特定专业知识的特别需求。PRMS上的成员资格被轮换 会籍期限至少为三年。五个临床 设施隶属于SACI(CTRC，大学医院，弗吉尼亚州 圣路加浸信医院)。所有在圣路加浸信医院进行的方案 附属公司必须通过UTHSCSA的IRB获得批准，并且 对SACI临床从属关系的要求包括承认 PRMS的权威和对附属公司行为的禁止 尚未公布的癌症相关临床方案说明书 由PRMS批准。临市局的检讨和规定已提交至 各附属机构研究委员会主任。全 方案必须有临床科室主任的签字 其成员是首席研究员的医学院。《椅子》 签字认可调查员必须提交 PRMS审查的协议。 合作小组的协议得到了快速的PRMS审查，而所有 其他与癌症相关的临床研究方案必须完全提交 对PRMS的详细科学审查。提交审查的议定书有 在任何地方进行的与癌症相关的治疗研究 加入或寻求访问SACI共享资源。定义的协议 提交由PRMS办公室根据委托人确定 已通过自愿提交确定调查员的身份，每月 审查IRB计算机文件、审查合作邮件、电话 致电合作组成员机构办公室，或致电 主要肿瘤科的既定礼宾办公室协调员 SACI附属机构的纪律。项目经理每月开会，并 目标是PRMS审查将在IRB完全批准之前进行 PRMS审查将及时提供，以便提交修订 在IRB全面审查的时候。内部审查委员会审查利用PRMS审查 在其审议和PRMS审查中的结果往往是 影响内部审查委员会的决定。在PRMS审查时，每个协议都是 分配了主要审核人和次要审核人，并被审查为科学 理论基础，适当的研究设计，患者应计费用估计， 生物统计学原理和完成时间的估计。 所审查的协议可以是完全批准的、下面批准的 对规定的满意答复，提交或无条件 被拒绝了。 当议定书获得批准后，将制定一个时间表供委员会审查 礼宾应计委员会。调查人员必须提交年度报告 在研究结论总结的三个月内提交最终报告 研究进展。调查人员还被要求提交 有关协议条目的人口统计信息。PRMS被授权有权 在调查员未能充分完成的情况下终止协议 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以下目标的准则 应计目标。PRMS设定了全面的机构优先顺序 所有议定书，并要求澄清冲突。PRMS有 制定了协议激活和访问的优先顺序方案 由机构调查员发起的共享资源 将方案作为合作小组研究的第一优先事项 药学赞助的研究分别位居第二和第三。

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.