Japan MHLW Ordinance 28 Good Clinical Practice for Drugs, 12/12
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Japan’s Ministerial Ordinance on Good Clinical Practice for Drugs was published to provide the GCP standards to ensure the scientific quality of clinical trials and the reliability of clinical trial data while protecting and promoting the rights, safety, and welfare of human subjects.
This 1997 (last amended in 2012) ordinance was made available in English in 2013.
For computer and software topics, refer to:
- Chapter II, Article 10 Prior Submission of Documents to the Head of Medical Institutions
- Chapter II, Article 12 Out-Sourcing of Duties
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