Search results with tag "Integrated addendum"
I ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD …
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
Guideline for good clinical practice E6(R2)
www.ema.europa.euIntegrated Addendum to ICH E6(R1) document. Changes are ... Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance
ICH HARMONISED GUIDELINE - ICH Official web site
www.ich.org1 INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE ICH E6(R2) INTRODUCTION Good Clinical Practice (GCP) is an international ethical and scientific quality standard for
Integrated Addendum to ICH E6(R1): Guideline for Good ...
database.ich.org2/8/2017 4 7 Integrated Format of the Addendum •The addendum supplements ICH E6(R1) with additional text. •This guideline should be read in conjunction with other ICH guidelines relevant to clinical trial conduct (for example, ICH E2A, E3, E7, E8, E9, and E11).