We provide a banking service for storing samples collected in clinical trials for pharmacogenomic research purposes, etc. in the storage area of our laboratory under the control of a manager.
Within the operation period of clinical trials, an appointed study director and study personnel accept and store the samples received in accordance with the study plan issued in advance.
After the study termination (long-term storage period), the gene manager takes over the management. If necessary, periodic reports are issued with numbers of samples stored and temperature conditions.
The storage area is in the banking room in the GLP area under strict access control. Temperature of the storage is strictly monitored by a temperature and humidity data acquisition system 24 hours a day. Anonymization is conducted under direct supervision of a gene manager by an anonymization system, after which the samples are identified with a 2D barcode of assigned control numbers. Personal information of the subjects is totally protected with 2 ID numbers, an accession number assigned within the clinical study period and a control number assigned at anonymization.
