The Clinical Laboratory Core will be responsible for providing study recruitment, scheduling, enrollment and retention support, along with biological specimens to all of the projects. The Core will be responsible for maintaining the rights of human subjects and will process and provide the clinical biological specimens needed for the individual projects. By coordinating all clinical biological specimen processing activities in this Core, the Projects will realize a substantial cost savings. Importantly, by centralizing the specimen processing, it becomes possible to optimize the use of human specimens for as many experiments as possible and, [coordinate the sharing of specimens for simultaneous experiments conducted in Projects 1 and 3]. The Clinical Laboratory Core will provide the following five services: 1) study subject recruitment, scheduling, enrollment and retention support, including data entry of results obtained from these activities;2) ensure protection of human subjects;3) standardize specimen handling and distribution;4) maximize utilization of biological specimens and ensure cost savings;and 5) provide standardized laboratory procedures for blood and bronchoalveolar lavage cells. Along with this, the Core will ensure that laboratory and clinical data generated through the Core are entered into the appropriate databases and are available to Project Leaders as needed. Interaction with Projects and Cores: The Clinical Laboratory Core will interact with the Administrative Core, as it provides the administrative and organizational structure to support this grant mechanism and the synergy between the Projects and Cores. This Core will report to the Administrative Core at monthly meetings of the Executive Committee and provide reports on its activities as needed otherwise. The Clinical Laboratory Core will work with the Biostatistics and Exposure Core which will set up and maintain databases, generate study identification numbers and perform routine data quality checks. The Clinical Laboratory Core will report to the Biostatistics and Exposure Core as to the subjects that are enrolled, so that they may obtain data from the clinical and demographic cohort databases as needed for data analysis for the individual Projects. This notification will trigger an exposure reconstruction to begin through the Biostatistics and Exposure Core staff, as appropriate for subjects enrolled in Projects 2 and 3. These measures will serve all Projects and result in considerable cost savings to the grant.
The reason some workers develop sensitization or disease when exposed to beryllium and others do not, is likely due to immune, genetic and exposure factors. The Clinical Laboratory Core will ensure the recruitment of subjects from a number of workforces, standardization of laboratory procedures and assurance of Human Subjects protection for all Projects in this POI. The Projects'results derived will have important public health implications regarding biomarkers, potential therapeutics and safe exposure limits applicable to industry.
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