Clinical Characterization and Biorepository Core

临床特征和生物库核心(CCBC)为ORDRCC研究人员提供了访问独特的患者集合和新的招聘机会，以帮助他们的风湿病研究计划和帮助促进他们的职业发展。这一核心为以患者为导向的研究培训、患者/对照识别和招募、样本处理以及获取大量患者和对照样本以及相关的临床、人口统计、治疗和疾病活动措施提供了一个集中的过程。根据最近在资金方面的一些变化，临床特征和生物库核心将包括以前的ORDRCC样本采购和管理核心(SPMC)，以及来自历史上的狼疮家族注册和存储库的样本和数据，以促进ORDRCC调查人员和初级调查人员的临床调查。OMRF SPMC是在ORDRCC的资助下建立的，并支持了37名ORDRCC初级调查人员(从南卡罗来纳州到阿拉斯加，从芝加哥到加利福尼亚州，来自俄克拉荷马州内外)和19名ORDRCC中心调查人员的项目。临床特征和生物信息库核心的目标是： 1)促进人类受试者的招募、重新联系、同意和遵守。CCBC确保受试者招募、临床评估和样本捐赠程序符合良好临床实践的严格标准。通过在知情同意、监管报告、监督临床研究参与者的福利以及使用经过验证的疾病活动工具提供专家临床评估方面的服务，CCBC支持并扩大了所有ORDRCC研究人员的研究机会。 2)向ORDRCC调查人员提供过程和代码样本。CCBC确保对人体生物样本进行及时、协议驱动的处理、编码、存储和跟踪。 3)为ORDRCC研究项目提供样本和相关临床数据。广泛的临床、人口学、疾病活动和疾病损害数据存在于登记了系统性风湿病的患者中。CCBC将使ORDRCC调查人员了解各种患者并控制临床信息和相关样本，这将对他们的各种项目有用。 4)培训ORDRCC人类课题研究的初级研究员。ORDRCC帮助确保对所有ORDRCC人员进行适当的HIPAA和人类受试者培训，并培训使用OMRF自身免疫病研究所中央数据系统的人员。

The Clinical Characterization and Biorepository Core (CCBC) provides ORDRCC investigators with access to unique patient collections and new recruitment opportunities to aid their rheumatic disease research programs and to help facilitate their career development. This Core provides a centralized process for patient-oriented research training, patient/control identification and recruitment, and sample processing, as well as access to large collections of patient and control samples with associated clinical, demographic, therapeutic and disease activity measures. Based upon some recent changes in funding, the Clinical Characterization and Biorepository Core will encompass the previous ORDRCC Sample Procurement and Management Core (SPMC), along with samples and data from the historical Lupus Family Registry and Repository, to facilitate the clinical investigation of ORDRCC investigators and junior investigators. The OMRF SPMC was established with the funding of the ORDRCC, and has supported projects from 37 Junior ORDRCC Investigators (both from inside and outside Oklahoma, spanning from South Carolina to Alaska and from Chicago to California) and 19 ORDRCC Center Investigators. The goals of the Clinical Characterization and Biorepository Core are to: 1) Facilitate human subject recruitment, re-contact, consent and compliance. The CCBC ensures that human subject recruitment, clinical assessments and sample donation procedures meet rigorous standards of good clinical practice. By performing services in informed consent, regulatory reporting, oversight of the welfare of clinical study participants, and provision of expert clinical assessments using validated disease activity instruments, the CCBC supports and expands the research opportunities of all ORDRCC investigators. 2) Process and code samples provided to ORDRCC investigators. The CCBC ensures timely, protocol-driven processing, coding, storage and tracking of human biologic samples. 3) Provide samples and associated clinical data to ORDRCC research projects. Extensive clinical, demographic, disease activity and disease damage data exists on patients enrolled with systemic rheumatic diseases. The CCBC will make ORDRCC investigators aware of various patient and control clinical information and associated samples, which will be useful for their various projects. 4) Train ORDRCC junior investigators in human subject research. The ORDRCC helps ensure appropriate HIPAA and human subjects training of all ORDRCC personnel and training of personnel in use of the central OMRF Autoimmune Disease Institute data system.