Core--Human Subjects

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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.