The Differences of Laws and Ethical Guideline to Clinical Studies that Researchers Should Know After Effectuation of Clinical Trials Act ―The Variances of GCP Ordinance, Clinical Trials Act, and Ethical Guidelines for Medical and Health Research Involving Human Subjects―

DOI Web Site 2 Citations
  • UCHIKURA Takeshi
    Showa University Research Administration Center, Japan Department of Hospital Pharmaceutics, School of Pharmacy, Showa University, Japan
  • KOBAYASHI Shinichi
    Showa University Research Administration Center, Japan Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics, Japan
  • RYU Kakei
    Showa University Research Administration Center, Japan Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics, Japan
  • SAMBE Takehiko
    Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics, Japan Department of Clinical Pharmacology, School of Medicine, Showa University, Japan
  • HIDA Noriko
    Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics, Japan Department of Clinical Pharmacology, School of Medicine, Showa University, Japan
  • UCHIDA Naoki
    Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics, Japan Department of Clinical Pharmacology, School of Medicine, Showa University, Japan

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  • 臨床研究法施行後の研究者が知っておくべき臨床研究に関する法・基準の差異について―GCP 省令，臨床研究法，及び倫理指針の差異―

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