Resource Core

项目总结 临床和社区资源核心将建立在MCRC患者建立的坚实基础上 MUSC在过去4年中的资源核心。自2012年以来，这一核心服务于地方、国家、国际、 和企业基础，通过提供以非裔美国人为主的良好表型纵向队列 系统性红斑狼疮(SLE)和系统性硬化症(SSC)患者和匹配的对照数据和 储存的生物样本。最近对研究基础的一项正式调查表明，现在的需求超过了 MCRC的基础设施。首先，研究人员需要对患有特定疾病的患者进行更密集的纵向随访 疾病亚型，如硬皮病、间质性肺病和狼疮性肾炎。第二，新鲜 此外，还需要外周血单个核细胞和皮肤活检等生物样本 保存的标本。第三，需要额外的协调器支持，以促进有效收集新鲜数据 标本并协助满足法规要求。最后，翻译科学家和初级调查人员 需要就与社区接触、针对疾病的研究设计和数据进行咨询 解释、提案可行性分析和灵活调整核心服务以适应其 需要。临床和社区资源核心(CCR核心)将灵活地扩展服务，通过提供 能够在医疗记录中更精细地对患者进行表型分析，以便有效地招募患者进行研究 并在预定的临床就诊期间更严格地遵循纵向队列。自动报告特定的 SLE和SSC表型将有助于更有效地远程订购生物标本。这种自动化 将使我们能够重新集中协调员的资源，以增加MCRC涵盖的诊所就诊百分比 并满足研究基地的要求。核心的具体目标是：1)保持和灵活扩展 CCR核心具有新的电子健康记录(EHR)基础设施，以提供良好的表型、纵向 SLE和SSC受试者队列以及匹配的对照志愿者，以支持 研究基地；2)维护并灵活扩展CCR核心，使用新的EHR基础设施高效地提供 良好的表型、储存和新鲜的生物标本，来自现有的纵向范围内和之外 根据研究基地正在进行的和预测的未来需求进行队列；3)提供资源以联系 受SSC和SLE影响的社区和研究过程中的调查人员，从项目规划到 传播和促进健康，通过与社区成员、社区组织和 患者权益倡导团体；以及4)为当前和未来的项目提供咨询和监管支持 研究基地。没有其他资源可以提供这一独特种群的优良表型数据和样本 病人。由核心推动的社区参与可以增加所进行研究的相关性 通过该基地以及将其翻译到具有已知健康差异的SLE和SSC患者社区。

PROJECT SUMMARY The Clinical and Community Resource Core will build on the strong foundation established by the MCRC Patient Resource Core at MUSC during the past 4 years. Since 2012 this core has served a local, national, international, and corporate base by providing a well phenotyped longitudinal cohort of predominantly African-American systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) patients and matched control data and banked biological samples. A recent formal survey of the research base indicated that needs are now exceeding the MCRC infrastructure. First, investigators need more intensive longitudinal follow-up of patients with specific disease sub-phenotypes such as scleroderma interstitial lung disease and lupus nephritis. Second, fresh biological specimens such as peripheral blood mononuclear cells and skin biopsies are needed in addition to banked specimens. Third, additional coordinator support is needed to facilitate efficient collection of fresh specimens and assist with regulatory requirements. Finally, translational scientists and junior investigators require consultation about engagement with the community, disease-specific study design and data interpretation, proposal feasibility analysis, and methods for flexibly adapting the services of the core to their needs. The Clinical and Community Resource Core (CCR Core) will flexibly expand on the services by providing the ability to more finely phenotype patients in the medical record in order to efficiently recruit patients for studies and more rigorously follow the longitudinal cohort during scheduled clinical visits. Automated reporting of specific SLE and SSc phenotypes will facilitate more efficient remote ordering of biological specimens. This automation will enable us to refocus coordinator resources to increase the percentage of clinic visits covered by the MCRC and fulfill requests by the research base. The core’s specific aims are to: 1) Maintain and flexibly expand the CCR Core with novel electronic health record (EHR) infrastructure to provide a well phenotyped, longitudinal cohort of SLE and SSc subjects and matched control volunteers to support the current and future needs of the research base; 2) Maintain and flexibly expand the CCR Core with novel EHR infrastructure to efficiently provide well phenotyped, banked and fresh biological specimens, both from within and beyond the existing longitudinal cohort, based on the ongoing and projected future needs of the research base; 3) Provide resources to link communities impacted by SSc and SLE and investigators in the research process, from project planning to dissemination and health promotion, by engaging with community members, community organizations and patient advocacy groups; and 4) Provide consultative and regulatory support to current and future projects of the research base. No other resource can provide fine phenotype data and samples from this unique population of patients. The community engagement facilitated by the core can increase the relevance of research performed by the base as well as its translation to a community of SLE and SSc patients with known health disparities.