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I ADDENDUM TO ICH E6(R1 ... - ICH Official web site
www.ich.orginternational conference on harmonisation of technical requirements for registration of pharmaceuticals for human use ich harmonised guideline integrated addendum to ich e6(r1): guideline for good clinical practice
I ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD …
www.ich.org1 1 INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR 2 GOOD CLINICAL PRACTICE ICH 3 E6(R2) 4 INTRODUCTION 5 Good Clinical Practice (GCP) is an international ethical and scientific quality standard for 6 designing, conducting, recording and reporting trials that involve the participation of human 7 subjects. Compliance with this standard provides public assurance that the rights, safety and