抄録
The clinical trials enforcement organization is progressing remarkably after the new GCP. An investigation of the clinical trials enforcement organization was undertaken focusing on the arrangement and the works of clinical research coordinator (CRC) for 79 university hospitals (national university hospitals: 42, public university hospitals: 8, private university hospitals: 29). The main investigation items were four: (1) the change of the number of CRC, (2) the kind of work of CRC and their starting time, (3) judgement situations of clinical trials and post-marketing surveillance, and (4) the installation situation of a clinical trials management center.
From April 1997 to April 2000, the number of CRC markedly increased from ten persons to 129.5 persons in the national university hospitals and from one person to 90 persons in the private university hospitals, but only a few changes were found in the public university hospitals. The occupational descriptions of CRC are mainly those of pharmacist and nurse. Although the measure for wide range CRC business is progressing, the measure for screening of participants is relatively late in both the national university hospitals and the private university hospitals.
Recently, the science nature and the ethics nature of clinical research other than clinical trials and post-marketing surveillance (in particular post-marketing clinical trials) are generally evaluated by the institutional review board (IRB), and the installa tion of a special center for managing and supervising the smooth advancement of clinical research is also progressing.
