Compliance With Good Clinical Practice in Oncology Registration Trials in Japan
Annals of oncology : official journal of the European Society for Medical Oncology / ESMO 2011 Jun; 22(6): 1451-6
This study aimed to examine the quality in oncology registration trials for new drug application (NDA) or supplemental new drug application (sNDA) as extensions of the indications for use in Japan based on Good Clinical Practice (GCP) audit findings.
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Adopts Consolidated Guideline on Good Clinical Practice in the Conduct of Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use Unknown author (1997)