Abstract:

The standard focuses on the management of renal biobank and technical specification of practice for biospecimen of patients with kidney diseases, including ethical and administrative license approval, staffing, preparation for biospecimen collection, biospecimen collection, biospecimen delivery and handover, biospecimen processing and aliquot, biospecimen storage, biospecimen utilization and sharing, onsite inspection and emergence plans, biospecimen transport, biospecimen discard and quality control for biobank. It described each technical points in detailed and put the concept of quality management system throughout the practice process, in order to help renal biobank personnels to build up standardized management and operation.

Key words: biobank, management, operation, specification, kidney diseases