Core--Human Subjects

人类学科核心(HSC)将服务于所有三个子项目，其任务是监督患者 保护。HSC将通过制定标准操作程序(SOP)来确保这种保护； 获得IRB批准并核实人类研究保护办公室(CHRP)进行这项工作的保证 研究性研究；提供需要认证的专家培训，以确保每个人都有资格 执行协议程序；并持续监测所有程序的遵守情况。HSC将 支持每个子项目如下： 子项目1(临床疗效)。每一地点临床人员的培训和认证；学习培训 人员筛选、登记、随机化和数据收集；数据安全监测培训。 次级项目2(行动机制)。对研究人员进行样本收集、处理和分析的培训 航运；数据安全监测、样品编码和识别。 次级项目3(费用和成本效益)。数据收集方面的研究人员培训(资源 单位、护理日志等)；监测数据安全(成本和资源使用数据)。 所有子项目。人类研究保护培训.IRB批准和OHRP保证.制定 标准操作规程和操作和程序手册；现场审计和监测；现场教育。

The Human Subjects Core (HSC) will serve all three subprojects and its mandate is to oversee patient protection. The HSC will assure this protection through development of standard operating procedures (SOPs); obtaining IRB approval and verifying Office of Human Research Protection (CHRP) assurances to conduct this research study; providing expert training that requires certification to ensure that each individual is qualified to execute protocol procedures; and ongoing monitoring of compliance with regard to all procedures. HSC will support each subproject is as follows: Subproject #1 (Clinical efficacy). Training and certifying of clinical personnel at each site; Training of study personnel for screening, enrolment, randomization and data collection; training monitoring for data safety. Subproject #2 (Mechanisms of action). Training of study personnel for sample collection, processing and shipping; Monitoring for data safety, sample coding and de-identification. Subproject #3 (Costs and cost-effectiveness). Training of study personnel for data collection (resource units, care logs etc.); Monitoring for data safety (cost and resource use data). All subprojects. Human research protection training; IRB approvals and OHRP assurances; Development of SOPs and Manual of operations and procedures; Auditing and monitoring of sites; Site education.