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ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice.
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2002
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International Conference On Harmonisation Of Technical Requirements For\nRegistration Of Pharmaceuticals For Human Use Recommended for Adoption\nat Step 4 of the ICH Process on 1 May 1996 by the ICH Steering\nCommittee This Guideline has been developed by the appropriate ICH\nExpert Working Group and has been subject to consultation by the\nregulatory parties, in accordance with the ICH Process. At Step 4 of\nthe Process the final draft is recommended for adoption to the\nregulatory bodies of the European Union, Japan and USA.i