Research Service Center

项目摘要。以肥胖为重点的密西西比中心的研究服务中心（RSC） 临床和转化研究（CCTR）将培训和协助来自所有合作伙伴的CCTR支持的研究者 研究开发和实施关键领域的机构，包括伦理、监管和 管理和合规，以及严格的标准化研究实践。临床专业人员和 社区参与的研究将确保研究者完成所有监管培训，满足所有监管要求， 要求，并为参与者的招募和保留以及最佳做法建立健全的程序 数据收集、监测和报告，以及遵守药物临床试验质量管理规范指南。一个训练有素 伦理学家将审查所有接受试点项目支持的项目，并与所有接受指导的调查人员会面 在研究者发展计划（专业发展核心）开始时， 以及任何新项目的开始。RSC人员将协助建立强有力的数据安全实践， 研究结果和不良事件的透明合规记录。他们将与 调查员制定完整和准确的预算，制定服务协议， 合同，并执行及时和准确的发票研究程序。RSC将提供 加强对临床研究协调员和社区研究协调员的访问， 共享使用和交叉覆盖，并将建立标准化临床研究软件的普遍使用。 研究服务中心将为试验计划的得奖者提供全面的服务支援，包括 专业发展核心的三个组成部分：研究者发展计划， 社区卫生研究所（CEnR）和CEnR工作组。此外，经批准， 在RSC领导人和CCTR指导委员会的领导下，RSC将与研究者、研究协调员， 和行业赞助商建立经济合理的肥胖研究，将提供收入 流，以维持和扩大RSC超过IDEA资助期。通过降低项目障碍 制定和实施并推广临床、转化和社区的最佳实践 参与研究，RSC可以导致道德和管理良好的肥胖研究的快速扩展 项目，并增加研究经费，在CCTR伙伴机构。

PROJECT SUMMARY. The Research Service Center (RSC) of the obesity-focused Mississippi Center for Clinical and Translational Research (CCTR) will train and assist CCTR-supported investigators from all partner institutions in key areas of research development and implementation, including ethics, regulatory management and compliance, and rigorous, standardized research practices. Professionals in clinical and community engaged research will ensure that investigators complete all regulatory training, meet all regulatory requirements, and establish robust processes for participant recruitment and retention as well as best practices in data collection, monitoring, and reporting, and adherence to Good Clinical Practice guidelines. A trained ethicist will review all projects that receive Pilot Projects support, and will meet with all mentored investigators in the Investigator Development Program (Professional Development Core) at the beginning of the program and at the start of any new project. RSC personnel will assist in establishing strong data security practices and transparent and compliant documentation of research results and Adverse Events. They will work with investigators to develop complete and accurate budgets, establish service agreements, seek fair and compliant contracts, and implement timely and accurate invoicing for research procedures. The RSC will provide enhanced access to Clinical Research Coordinators and Community Research Coordinators, with mechanisms for shared usage and cross-coverage, and will establish general use of standardized clinical research software. The RSC will provide full service support for awardees of the Pilot Projects Program, including participants in three components of the Professional Development Core: the Investigator Development Program, the Community Engaged Research (CEnR) Institute, and the CEnR Working Group. In addition, with the approval of RSC leaders and the CCTR Steering Committee, the RSC will work with investigators, study coordinators, and industry sponsors to establish economically sound obesity research studies that will provide a revenue stream to sustain and expand the RSC beyond the period of IDeA funding. By lowering barriers to project development and implementation and promoting best practices in clinical, translational, and community engaged research, the RSC can lead to a rapid expansion of ethical and well-managed obesity research projects, and increased research funding, at the CCTR partner institutions.