Sponsor's View for the Practice of Clinical Trials.

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  • NISHIHARA SHIGEKI
    Department of Hospital Pharmacy, Okayama University Medical School
  • FUTAGAMI KOUJIRO
    Department of Hospital Pharmacy, Okayama University Medical School
  • SADAKANE NORIAKI
    Department of Hospital Pharmacy, Okayama University Medical School
  • INOUE MAYUMI
    Department of Hospital Pharmacy, Okayama University Medical School
  • HIRAMATSU YOKO
    Department of Hospital Pharmacy, Okayama University Medical School
  • ARAKI HIROAKI
    Department of Hospital Pharmacy, Okayama University Medical School
  • KAWASAKI HIROMU
    Department of Clinical Pharmaceutical Science, Faculty of Pharmaceutical Sciences, Okayama University
  • GOMITA YUTAKA
    Department of Hospital Pharmacy, Okayama University Medical School

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  • 治験実施に対する治験依頼者の意見

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Abstract

Japanese Good Clinical Practices (GCP) guide, which was based on ICH-GCP, was revised in April 1998. Pharmacists must manage clinical trials under conditions that are in compliance with the GCP. We reviewed the clinical trials performed in our hospital using a questionnaire, regarding the monitoring and auditing system of these trials by sponsors. It was recognized that about 90% of sponsors had staff education and training programs on monitoring and auditing. In addition, most sponsor desired that the protocols are being followed by the support of clinical research coordinator (CRC), and thus cooperate to direct access to source data/document and transcribe such information onto the case report forms. These results may be useful to improve the quality and integrity of the data from clinical trials in our hospital. We consider it very important for each institutional administrator to understand the sponsor's view.

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