Clinical Protocol and Data Management Shared Resources

UTSW的所有临床肿瘤学研究都由临床方案和数据管理共享协调 资源（临床研究办公室; CRO）。CRO，沿着方案审查和监查 委员会（PRMC）和数据和安全性监查委员会（DSMC）是方案审查的一部分， 监测系统（PRMS），直接监督UTSW的所有临床肿瘤学研究活动 和癌症中心，并负责监督所有与患者相关的癌症研究。琼医生 癌症中心副主任Schiller担任CRO的医学总监。林恩贝克女士 MBA，临床研究助理主任，是行政主任。 CRO是与临床癌症研究相关的所有活动的临床协调中心， UTSW。它为肿瘤临床试验的监督、管理和监测提供了基础设施， 促进整个校园的高质量临床研究。这些活动的集中化确保了 规范临床研究的各个方面，确保患者安全和临床协调 研究活动。该资源还提供了一个癌症协议的中心位置， 目前正在进行的研究、方案的状态报告以及临床研究的质量控制和培训 人员和初级调查员。CRO还为PRMS和DSMC提供行政支持， 包括及时提交所有方案、修正案和监管文件;监测和 审核SCC协议，以确保符合所有法规;以及准确及时地提交 向监管机构提供数据。它评估和协助资源分配， 政策和程序。

All clinical oncology research at UTSW is coordinated by the Clinical Protocol and Data Management Shared Resource (Clinical Research Office; CRO). The CRO, along with the Protocol Review and Monitoring Committee (PRMC) and Data and Safety Monitoring Committee (DSMC), is part of the Protocol Review and Monitoring System (PRMS), which has direct oversight over all clinical oncology research activities at UTSW and the Cancer Center, and is responsible for oversight of all patient-related cancer research. Dr. Joan Schiller, Deputy Director of the Cancer Center, serves as Medical Director of the CRO. Ms. Lynn Baker, MBA, Assistant Director for Clinical Research, is the administrative director. The CRO serves as the clinical coordinating center for all activities related to clinical cancer research at UTSW. It provides infrastructure for oversight, management, and monitoring of oncology clinical trials, thus facilitating high quality clinical research throughout our campus. Centralization of these activities ensures standardization of all aspects of clinical research, ensuring patient safety and coordination of clinical research activities. The resource also provides a central location for cancer protocols, an updated list of currently active studies, status reports of protocols, and quality control and training for clinical research personnel and junior investigators. The CRO also provides administrative support for the PRMS and DSMC, including timely submission of all protocols, amendments, and regulatory documents; monitoring and auditing of SCC protocols to ensure compliance with all regulations; and accurate and timely submission of data to regulatory bodies. It assesses and assists with resource allocation, and standardizes operational policies and procedures.