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.

The scope of the research encompassed by the four U19 investigator-initiated projects and the Technology Development Project would benefit not only from the shared cost of the resources of the proposed clinical core but also from the structure to standardize and disseminate new technologies that are developed within the individual projects.