Abstract
Abstract The quality of biospecimens and associated data accuracy in a Biobank must be collected and consistent according to standardized methods in order to achieve international harmonization and coordination among biobanking networks. Sharing successful strategies between the Baylor College of Medicine (BCM) Breast and Cancer Centers and Breast Center Buenos Aires (BCBA) was the fundamental stone for the creation of an Argentinean Breast Cancer oriented Biobank with a shared data management system. We have designed, developed and implemented a computer system to easily manage sensible associated data. This innovative system, allows the data entry in a visual, intuitive, friendly and orderly way, integrating all the information for further analysis and easy use of samples for translational research. Objective: Develop and improve (v2.0) a bilingual web-based tool for biospecimen management, inventory, clinical and breast cancer data registration according with international standards of data security quality assurance and ISBER Best Practices for Biorepositories. Methods: System Characteristics: Multi-tier architecture, relying on a SQL server 2008 R2 data base. Operating System: Windows Server Series. Programmer Language .net 4.0 C#.. The system operates with Internet Explorer as flat client or similar. Bilingual English/Spanish system, fully configurable by modules, HIPPA compliant sensible data confidentiality, with de-identification of samples through 2D bar codes. Results : System Capabilities and Improvements v2.0: • Security Module: Allows to manage predetermined profiles (Clinical Research Coordinator Clinical staff as Phlebotomist, Pathologist, PA, MDs, PhDs, Researchers), audit controls implemented through permits according to the profile. • Master Tables: allows to insert/add/change data associated into master tables, providing system user independence. • General Registration Module: Online statistics allows to see immediately the number of consented individuals, types of samples and their classification. • Sample Management: Assigns unequivocally identification of each sample in a 2D bar code for freezer lab labels(LabExpert®). Has online statistical information on the number of samples and tubes used, for an easy supply management. Automatically assigns the location of samples per product type in the freezer. Allows to know the occupancy rate online. • Breast Cancer Module: A comprehensive data base in an attractive visual environment of eight screens: Clinical data, Biopsy, Definitive Surgery, Systemic Treatment, Radiation Treatment, Cancer Events, follow up and Summary screen. Includes path reports and sample collection forms attached in each corresponding biopsy or surgery screen for easy view and data entry quality assurance. Conclusion: This Biobank Management System was designed in a friendly and intuitive data entry environment by a multidisciplinary team including breast surgeons, pathologists, oncologists, statisticians, system engineers and programmers from BCM and BCBA. It could be adapted to be used in full or in separate modules by Breast Centers and Breast Cancer Oriented Biobanks. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-19-04.
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