Clinical Trials Office

临床试验办公室核心(CTO)为KCI提供全面的临床试验资源和支持 会员和附属机构的最高优先事项是参与主体的安全。这个 CTO以最高的道德标准运作，确保和维护KCI ciinicai试验的合规性 与内部政策和外部管理机构的关系。首席技术官的主要和持续目标是： 确保在KCI进行的所有临床试验严格遵守 联邦法规(CFR)和国际协调会议(ICH) 良好临床实践(GCP)指南。这是在韦恩夫妇的监督下共同完成的 州立大学人类调查委员会。 ？通过提供合格的、经过专门培训的数据，促进和优化临床试验的应计费用 为KCI医生和临床支持人员提供管理和研究护士支持。 通过促进和优化医生-患者-CTO工作人员的互动，确保研究协调， 沟通和协作。 ？促进监管批准和监督，以快速审查和启动适当的试验。 CTO协调并确保遵守数据和安全监控计划(DSMP)，该计划 向议定书审查和监测委员会提供协调和行政支助 数据和安全监测委员会和质量保证委员会。此外，首席技术官 作为特定于协议的记录IRB的接口，以便于准备所需的法规 加快及时批准KCI议定书所需的文件。首席技术官还负责协调注册 和维护NCI临床试验报告计划的所有治疗方案，以及 临床试验.gov。首席技术官支持NCI资助的同行评审协议、研究人员发起的研究， 行业赞助协议和SWOG、COG、GOG、RTOG协作组协议以及 其他专业合作社小组。超过80个全职员工作为会员提供数据管理服务 CTO，支持大约350个活动协议。这些活动已导致 在这一赠款期间，在代表少数族裔和妇女的情况下进行治疗性临床试验的应计费用 反映KCI所服务的社区。

The Clinical Trials Office Core (CTO) provides comprehensive clinical trials resources and support to KCI members and affiliate institutions with the highest priority being the safety of participating subjects. The CTO functions to the highest ethical standards ensuring and maintaining compliance of KCI ciinicai trials with internal policies and external governing bodies. The primary and continuing goals ofthe CTO are to: ¿ Ensure that all clinical trials conducted at KCI are carried out in strict compliance with the Code of Federal Regulations (CFR) and in accordance with Intemationai Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. This is done in conjunction and with oversight by the Wayne State University Human Investigation Committee. ¿ Facilitate and optimize accrual to clinical trials by providing well qualified, specifically trained data management and research nurse support to KCI physicians and clinical support staff. ¿ Ensure research coordination by facilitating and optimizing physician-patient-CTO staff interaction, communication and collaboration. ¿ Facilitate regulatory approval and oversight to rapidly review and activate appropriate trials. The CTO coordinates and ensures compliance with the Data and Safety Monitoring Plan (DSMP), which irilSlu'des coordination and administrative support to the Protocol Review and Monitoring Committee, the Data and Safety Monitoring Committee and the Quality Assurance Committee. Additionally, the CTO serves as an interface with the protocol specific IRB of record to facilitate preparation of required regulatory documents necessary to expedite timely approval of KCI protocols. The CTO also coordinates registration and maintenance of all therapeutic protocols to the NCI's Clinical Trial Reporting Program and ClinicalTrials.gov. CTO supports NCI-funded peer reviewed protocols, investigator-initiated studies, industry sponsored protocols and the cooperative group protocols of SWOG, COG, GOG, RTOG, as well as other specialty cooperative groups. Over 80 FTEs provide data management services as members of the CTO in support of approximately 350 active protocols. These activities have resulted in a 76% increase in accrual to therapeutic clinical trials during this grant period with representation of minorities and women that reflect the communitv that KCI serves.