Clinical Trials Office

临床试验办公室

• 批准号: 8350787
• 负责人: LAWRENCE E FLAHERTY
• 金额: $ 28.1万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-06 至 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8350787
• 关键词: Administrative Coordination; Cancer Patient; Case Report Form; Categories; Clinical; Clinical Practice Guideline; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Code; Collaborations; Collection; Communication; Complex; Conduct Clinical Trials; Consent; Data; Data Base Management; Discipline; Ensure; Environment; Ethics; Funding; Genomics; Goals; Good Clinical Practice; Grant; Growth; Gynecologic Oncology Group; Health Insurance Portability and Accountability Act; Human; Image; Industry; Institutes; Institution; Institutional Review Boards; Instruction; International; Investigation; Kinetics; Maintenance; Malignant Neoplasms; Measures; Minority; Monitor; Nursing Research; Oral; Patients; Peer Review; Pharmaceutical Preparations; Phase I Clinical Trials; Physicians; Policies; Preparation; Procedures; Production; Protocols documentation; Qualifying; Quality of life; Radiation Therapy Oncology Group; Regulation; Reporting; Research; Research Infrastructure; Research Personnel; Resource Sharing; Resources; Safety; Services; Site; Southwest Oncology Group; System; Therapeutic; Therapeutic Clinical Trial; Time; Training; Universities; Woman; cancer therapy; data management; design; diaries; follow-up; improved; medical specialties; member; operation; programs; quality assurance; symposium; tool

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.

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 成员和附属机构的最高优先级是参与受试者的安全。的 首席技术官的职能符合最高道德标准，确保和维持KCI临床试验的合规性 内部政策和外部管理机构。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都严格遵守 联邦法规（CFR）和国际协调会议（ICH） 药物临床试验质量管理规范（GCP）指南。这是在韦恩的监督下完成的 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收益 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性监测计划（DSMP）， irilSlu 'des向议定书审查和监测委员会提供协调和行政支持 数据和安全监测委员会和质量保证委员会。此外，CTO 作为与方案特定IRB记录的接口，以便于准备所需的监管 加快及时批准KCI方案所需的文件。CTO还负责协调注册 并维护NCI临床试验报告计划的所有治疗方案， ClinicalTrials. gov. CTO支持NCI资助的同行评审方案、研究者发起的研究， 工业发起的协议和SWOG、COG、GOG、RTOG的协作组协议，以及 其他专业合作社。超过80名全职员工作为 首席技术官支持大约350个活跃的协议。这些活动导致了76%的增长， 在此补助期间，少数民族和妇女的代表性， 反映了KCI所服务的社区。