Clinical Characterization and Biorepository Core

临床特征和生物样本库核心

基本信息

批准号：
8535610
负责人：
ELIZA F CHAKRAVARTY
金额：
$ 27.42万
依托单位：
OKLAHOMA MEDICAL RESEARCH FOUNDATION
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-01 至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/8535610
关键词：
Address Alaska Autoimmune Diseases California Chicago Clinical Clinical Data Clinical Research Clinical Trials Clinical assessments Code Collection Consent Data Disease Enrollment Ensure Family-Based Registry Funding Future Glean Goals Good Clinical Practice Health Health Insurance Portability and Accountability Act Human Human Resources Human Subject Research Individual Information Systems Informed Consent Institutes Lupus Measurement Measures Oklahoma Participant Patients Procedures Process Protocols documentation Reporting Research Research Personnel Research Project Grants Research Training Resources Rheumatism Sampling Services Social Welfare South Carolina Therapeutic Training Venous blood sampling base biobank career development cohort human subject human subject protection instrument meetings member patient oriented research programs repository

项目摘要

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.

临床表征和生物座席核心（CCBC）为ORDRCC调查人员提供了独特的患者收集和新的招聘机会，以帮助其风湿病研究计划，并帮助促进其职业发展。该核心为以患者为导向的研究培训，患者/对照识别和招聘以及样本处理提供了集中式过程，以及访问大量患者和控制样品，并具有相关的临床，人口统计学，治疗和疾病活动测量。基于最新资金变化，临床表征和生物座核将涵盖先前的ORDRCC样品采购和管理核心（SPMC），以及历史狼疮家庭注册表和存储库的样品和数据，以促进ORDRCC研究人员和Junior研究人员的临床研究。 OMRF SPMC是通过ORDRCC的资金建立的，并支持了37名初级ORDRCC调查人员（来自俄克拉荷马州内部和外部，从南卡罗来纳州到阿拉斯加和从芝加哥到加利福尼亚州到加利福尼亚州）的项目和19位ORDRCC中心调查人员。临床表征和生物座核的目标是： 1）促进人类受试者的招募，重新接触，同意和遵守。 CCBC确保人类受试者招募，临床评估和样本捐赠程序符合严格的良好临床实践标准。通过在知情同意，监管报告，对临床研究参与者福利的监督以及使用经过验证的疾病活动工具提供专家临床评估的服务中，CCBC支持和扩大所有ORDRCC研究人员的研究机会。 2）提供给ORDRCC调查人员的过程和代码样本。 CCBC确保人类生物学样品的及时，协议驱动的处理，编码，存储和跟踪。 3）向ORDRCC研究项目提供样品和相关的临床数据。在患有全身风湿病的患者上存在广泛的临床，人口统计学，疾病活动和疾病损害数据。 CCBC将使ORDRCC调查人员了解各种患者和控制临床信息以及相关样本，这将对其各种项目有用。 4）培训人类学科研究中的ORDRCC初级调查员。 ORDRCC有助于确保适当的HIPAA和人类受试者对所有ORDRCC人员培训以及对使用中央OMRF自身免疫性疾病研究所数据系统的人员培训。