[Attempt to standardize clinical tests for the purpose of quality management in the field of clinical studies and clinical trials]

The purpose of this study was to contribute to the quality management in the fields of clinical studies and clinical trials. To accomplish this purpose we tried to make guidelines for nationwide standardization of clinical tests. This study was performed by multidisciplinary personnel such as medical doctors, medical technologist, CRC, and representatives of pharmaceutical companies and/or clinical laboratory testing companies. The study was also focused on two fields of clinical tests such as pre-analytical and post-analytical phase. Each member shared various incidents and tried to make solutions. In post-analytical area in particular, further discussion concerning CDISC and SS-MIX was done. Based on these efforts, a tentative guideline was made.