Early Phase Clinical Research Support

早期临床研究支持

• 批准号: 9334735
• 负责人: IAN M. THOMPSON
• 金额: $ 21.82万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9334735
• 关键词: Agreement; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Communication; Conduct Clinical Trials; Conflict (Psychology); Consent; Data; Eligibility Determination; Enrollment; Ensure; Ethics; Guidelines; Health Services Accessibility; Institutional Policy; Logistics; Malignant Neoplasms; Monitor; NCI Center for Cancer Research; Patients; Phase; Preparation; Protocol Compliance; Protocols documentation; Regulation; Reporting; Research; Research Infrastructure; Research Personnel; Research Support; Safety; Schedule; Serious Adverse Event; System; Testing; Time; Training; Training and Education; cancer therapy; data integrity; data management; member; online repository; operation; quality assurance

The Clinical Protocol and Data Management component of the Cancer Therapy & Research Center (CTRC) includes the Clinical Trials Office (CTO) and Data and Safety Monitoring Committee (DSMC) activities including the Quality Assurance Division (QAD). The CTO provides central management, research support and oversight functions for the conduct of cancer-related clinical trials at the CTRC. CTO services are available to all members of CTRC engaged in clinical research; however some researchers elect to use research staff within their departments working in concert with CTO to provide umbrella oversight. The major functions of the CTRC CTO are to: Facilitate timely activation and administration of clinical trials, including preparations and communications required for scientific, ethical, operations and logistics reviews • Ensure the research team is adequately trained to support each trial • Maintain a centralized web-based repository of all protocol specific documents and consents Provide clinical assistance to facilitate the conduct of clinical trials including but not limited to enrollment and verification of patient eligibility, scheduling of appropriate tests, treatments, and assessments • Provide data management support for clinical trials The QAD is separate from the CTO to minimize conflicts. Working with the DSMC, the functions of the QAD are to: Ensure that all reports, including reports of serious adverse events and unanticipated problems, are submitted in accordance with appropriate guidelines. Ensure protocol compliance with institutional policies and agreements, state and federal regulations, data accuracy and data integrity through a system of monitoring and quality assurance Provide training and education regarding best practices in conducting clinical trials to investigators and staff.

癌症治疗与研究中心（CTRC）的临床方案和数据管理组件 包括临床试验办公室（CTO）和数据和安全监测委员会（DSMC）活动 包括质量保证部（QAD）。首席技术官提供中央管理、研究支持 以及在CTRC开展癌症相关临床试验的监督职能。CTO服务 CTRC所有参与临床研究的成员均可使用;然而，一些研究人员选择使用 各部门的研究人员与首席技术官合作，提供全面监督。主要 CTRC CTO的职能是： 促进临床试验的及时启动和管理，包括准备和沟通 需要进行科学、道德、业务和后勤审查 ·确保研究团队得到充分的培训，以支持每项试验 ·维护一个集中的基于网络的所有协议特定文件和同意的存储库 提供临床协助，以促进临床试验的开展，包括但不限于入组 以及患者资格的验证，安排适当的检查、治疗和评估 ·为临床试验提供数据管理支持 QAD与CTO分开，以尽量减少冲突。与DSMC合作，QAD的功能 是： 确保所有报告，包括严重不良事件和非预期问题的报告， 按照适当的准则提交。 确保方案符合机构政策和协议、州和联邦法规、数据 通过监测和质量保证系统确保数据的准确性和完整性 向研究者提供关于开展临床试验的最佳实践的培训和教育， 工作人员