This Program Project will require an integrated suite of tools to support the proposed information-intensive studies in a cost effective and efficient manner. The spectrum of needs, from those of a basic scientist to those of an outcomes-based clinical investigators requires a robust architecture of software, hardware and information technology professionals to develop and maintain these tools. The cost of equipment, the rapid pace of technology development and the specialized expertise (e.g. clinical trials support, information management, data managers, quality control tools, tissue banking informatics and honest brokers systems, HIPAA compliance specialists, bioinformatics analyst, network/storage specialists, etc...) required to properly manage the informatics needs of the Program Project are not possible without high quality and efficient Cancer Informatics Services (CIS). It is therefore critical that this resource be well supported and integrated into the research and clinical missions of this PPG. The CIS team is a lead developer for the Cancer Biomedical Informatics Grid (caBIG) and all of the data sharing services offered will communicate with NCI data grid. The CIS proposed for this PPG is composed of the following integrated services: 1) Clinical Trials Management Application - this tool manages all of the clinical trials data and formats it for analysis 2) Tissue Banking Information Systems - the CIS core supplies the Core with the tools to support pathologic annotation and inventory control of the biospecimen (tissue, blood, serum and body fluids) requests of the program project researchers. These software tools developed by CIS assist in providing a secure environment for the collaborative honest broker activities of the Core. 3) Registry Research Information Services - supporting all of the clinical and outcomes annotation of patients in clinical trials and who contribute their cancer tissues to the tissue bank 4) Organ Specific Databases-a data mining tool for organ site specific programs that facilitates HIPAA compliant and de-identified access to patient tumor stage, grade, etc, as well as study cohort availability 5) Data Sharing, Storage, Archival and Network Services - robust network and storage solutions for clinical trials, tissue banking, data sharing and data archiving with active data maintenance and back up will be caBIG compliant. Innovative tumor immunology discovery relies on robust research information services to more effectively support the translation of innovation from the laboratory to the bedside and to utilize critical clinical and outcomes data to guide discovery at the bench and vice versa. This will be the key focus of the CIS in support of this PPG.
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