California Precision Medicine Consortium

将汇集精准医学计划登记和保留(Premier)队列，以反映 加利福尼亚州的不同人口。我们的目标是招收至少10,000名代表性参与者 12个月。参与者将同意使用NIH中心IRB协议，并将共享生物样品， 人体测量数据(例如，腰围)、调查答复和电子健康记录(EHR) PMI队列计划(PMI-CP)。参与者将通过多种媒体参与，包括非专有媒体 由PMI-CP开发的应用程序。包括六个大型医疗保健提供者组织 加州在Premier队列中将确保我们达到招生目标。促进与客户的交互 PMI-CP领导层，加州大学圣地亚哥分校将设立一个项目管理办公室(PMO)，负责 与每个机构的现场PI进行的所有沟通。重要的是，我们庞大而多样的经验丰富的财团 研究人员有着悠久的历史，过去的合作和富有成效的科学互动，创造了大量的 提高公共研究资源的使用效率，进一步保证我们将履行我们的 合同义务。这一协作包括对所有 我们的患者(我们六个初始参与机构的1000万患者)进入观察医学 成果伙伴关系(OMOP)和PCORnet共同数据模型(CDM)。来自PMI参与者的数据将是 集中在UCSD，后者将这些数据提交给数据和研究支持中心(DrSc)。我们预计 与参与者技术中心(PTC)和DRSC以及NIH保持密切联系 行政部门确保总理成员是各种PMI-CP工作组的积极参与者。 我们准备实施NIH Central IRB协议，并快速调整现有流程或采用新的流程 符合PMI-CP协议的设备。

The PREcision Medicine Initiative Enrollment and Retention (PREMIER) cohort will be assembled to reflect the diverse populations of California. Our goal is to enroll a minimum of 10,000 representative participants during a 12-month period. Participants will be consented using an NIH central IRB protocol and will share biospecimens, anthropometric data (e.g., waist circumference), survey responses, and electronic health records (EHRs) with the PMI Cohort Program (PMI-CP). Participants will be engaged through multiple media including non-proprietary applications developed by the PMI-CP. The inclusion of six large healthcare provider organizations throughout California in the PREMIER cohort will ensure that we meet our enrollment goals. To facilitate interactions with PMI-CP leadership, there will be a single program management office (PMO) at UCSD that will be charged with all communications to site PIs at each institution. Importantly, our large, diverse consortium of seasoned investigators has a long history of past collaboration and productive scientific interactions, creating substantial efficiencies in the use of common research resources, providing further assurance that we will fulfill our contractual obligations. This collaboration included the transformation and periodic updating of EHRs from all our patients (>10 million patients in our six initial participating institutions) into the Observational Medical Outcomes Partnership (OMOP) and PCORnet common data models (CDM). Data from PMI participants will be centralized at UCSD, which will submit these data to the Data and Research Support Center (DRSC). We expect to be in close contact with the Participant Technology Center (PTC) and the DRSC, as well as with NIH administration to ensure that PREMIER members are active participants in various PMI-CP Working Groups. We are ready to implement the NIH Central IRB protocol, and quickly adapt existing processes or adopt new ones to conform to the PMI-CP protocols.