Core--Human Subjects

人类受试者核心（HSC）将服务于所有三个子项目，其任务是监督患者 保护HSC将通过制定标准作业程序确保这种保护; 获得IRB批准，并验证人类研究保护办公室（CHRP）保证进行此 研究;提供需要认证的专家培训，以确保每个人都有资格 执行议定书程序;不断监测遵守所有程序的情况。HSC将 支持每个子项目的情况如下： 子项目#1（临床疗效）。各研究中心临床工作人员的培训和认证;研究培训 筛选、入组、随机化和数据收集人员;数据安全性培训监查。 次级项目2（行动机制）。对研究人员进行样本采集、处理和 运输;监测数据安全性、样品编码和去标识化。 次级项目3（成本和成本效益）。培训研究人员进行数据收集（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; SOP和操作手册和程序;研究中心的稽查和监测;研究中心教育。

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.