Clinical Core

临床核心

• 批准号: 8053889
• 负责人: MARYDAWN T CO
• 金额: $ 23.14万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8053889
• 关键词: Antigens; Biological Assay; Blood specimen; Cell Line; Characteristics; Clinical; Clinical Research; Cost Sharing; Development; Equipment and supply inventories; HLA Typings; Individual; Performance; Peripheral Blood Mononuclear Cell; Postdoctoral Fellow; Procedures; Process; Protocols documentation; Quality Control; Reagent; Registries; Research; Research Ethics Committees; Research Personnel; Research Project Grants; Resources; Sampling; Screening procedure; Serum; Services; Specificity; Specimen Handling; Structure; T-Lymphocyte; Testing; Venous blood sampling; interest; new technology; programs; protocol development; quality assurance; repository; research study; sample collection; technology development; volunteer

The Clinical Research Core will provide centralized, quality controlled services for specimen processing, regulatory protocol management, development of Standard Operating Procedures, and limited specialized assay testing to support the research of Projects 1,2,3 and 4. The core will be responsible for the identification, recruitment, and phlebotomy of individuals to support U19 research objectives as well as the regulatory oversight of IRB protocols related to U19 research. Through the efforts of research associates and technicians, the core will be responsible for the processing and storage of the blood and serum samples obtained. The core will be responsible for a Quality Control Materials program to provide services related to Quality assurance of reagents and assays used in U19 research. This would include the establishment and optimization of standardized protocols, the development of a centralized comprehensive repository of positive control cell lines, the establishment of subject registry related to immunological characteristics of interest and the performance of established T cell assays to determine antigen specificity of PBMC samples and reagents. In addition, the clinical research core will provide a limited number of HLA typings for each of the proposed U19 projects.

临床研究核心将为标本处理提供集中的质量控制服务， 监管协议管理，标准操作程序的制定以及有限的专业化 测定测试以支持项目1,2,3和4的研究。核心将负责 个体的识别，招募和静脉疾病，以支持U19研究目标以及 与U19研究有关的IRB方案的监管监督。通过研究伙伴的努力和 技术人员，核心将负责血液和血清样品的加工和存储 获得。核心将负责质量控制材料计划，以提供与 U19研究中使用的试剂和测定法的质量保证。这将包括机构和 优化标准化协议，开发集中式综合存储库 阳性对照细胞系，与免疫特征有关的主题注册处的建立 既定的T细胞分析的兴趣和性能，以确定PBMC样品的抗原特异性 和试剂。此外，临床研究核心将为每一个提供有限数量的HLA键入 拟议的U19项目。