RESUMEN
With the revision of the Good Clinical Practice (GCP) in 1997, the Clinical Trial Center was established at Saga University Hospital in 1999, where clinical research coordinators (CRC) of nurses and pharmacists have been carrying out support for clinical trials since June 2000. At present, two pharmacists, two nurses, and three clerical work assistants support the execution of clinical trials; however, in recent years the number of clinical trial commissions has been gradually decreasing. On this occasion, in order to carry out even higher quality and smoother clinical trials, we conducted a questionnaire targeting the sponsors of clinical trials (head monitors) to evaluate this hospital's system for the execution of clinical trials from the sponsor's standpoint. Moreover, for the purpose of comparison with the systems of other institutions, the same questionnaire was conducted on two other hospitals-the University of Occupational and Environmental Health, Japan and the Social Insurance Shimonoseki Kousei Hospital. The problems of the clinical trial execution in our team turned out lack of knowledge concerning GCP and our complex system from the result of the questionnaire.
Asunto(s)
Ensayos Clínicos como Asunto , Hospitales , Humanos , Japón , Enfermeras y Enfermeros , Farmacéuticos , Encuestas y CuestionariosRESUMEN
A clinical trial management room was established in the pharmacy at UOEH hospital in June, 2001, and we support the clinical trials in our hospital. Meanwhile, the number of clinical trials and CRC have increased as a result of this. Moreover, there have been changes in the work contents due to the introduction of the electronic clinical record system. At this time, we will report on the various current activities, and discuss the future problems.
