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进行协调 资源(临床研究室；CRO)。CRO，以及议定书审查和监测 (PRMC)以及数据和安全监测委员会(DSMC)，是议定书审查和 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。琼博士 席勒是癌症中心的副主任，担任CRO的医疗主任。尊敬的林恩·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，网址为 UTSW。它为肿瘤临床试验的监督、管理和监测提供基础设施，从而 在整个校园内促进高质量的临床研究。这些活动的集中化确保 规范临床研究各环节，确保患者安全和临床协作 研究活动。该资源还提供了癌症方案的中心位置、最新的 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 人事部和初级调查员。CRO还为PRMS和DSMC提供管理支持， 包括及时提交所有议定书、修正案和规范性文件；监测和 审核SCC协议，以确保遵守所有法规；并准确和及时地提交 将数据提供给监管机构。它评估和协助资源分配，并使运营标准化 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.