抄録
During a three-week long practical training program for pharmacy students at our hospital, senior pharmacy students had a one-day observation of pharmacists performing new drug investigations. Using a questionnaire survey we investigated whether the observation of the work of clinical research coordinator (CRC) influenced the student's understanding of the new drug investigation procedures. The observation of CRC's work consisted of counseling/interviewing prior to the doctor's consultation and visiting a clinical laboratory to observe new drug investigations. The items evaluated were impressions of the clinical investigation of new drugs, precautions for preparing investigational drugs, understanding the new Good Clinical Practice (GCP) guidelines and other important aspects in the clinical investigation. Each group consisted of 26 students. Only 10 out of 26 students observed counseling/interviewing before the doctor's consultation with CRC. The impression of the clinical investigation procedure in group I, which observed the CRC's work was more favorable than in group II, which did not observe it. The understanding of the important aspects of the clinical investigation procedures in group I was markedly better than in group II. We thus consider that the observation of the CRC work is very useful for students not only to learn new drug investigation procedures, but also to understand the meaning of the new GCP guidelines.