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Practice: Integrated. Addendum to ICH E6(R1). Guidance for Industry. U.S. Department of Health and Human Services. Food and Drug Administration. Center for ?—?, 13 1 2019 23:59:00. GMT reading good clinical practice pharmaceutical pdf. - GUIDELINE FOR GOOD. CLINICAL PRACTICE. ICH Harmonised Tripartite.Keywords, Good clinical practice (GCP), Ethics Committee, Institutional Review Board, investigator, sponsor, protocol, investigator's brochure, trial design, safety This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance 2 Aug 2016 E6(R1). Current Step 4 version dated 10 June 1996. (including the Post This Guideline has been developed by the appropriate ICH Expert Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects. GCP enforces tight guidelines on ethical aspects of a clinical study.