This document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
View this resource Bookmark this resourceGood Clinical Practice
ICH Guideline E6 on Good Clinical Practice
Published by EMAInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Good Clinical PracticeGCPThis document is the guideline of E6 on good clinical practice of The International Council for Harmonisation (ICH)
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European Commission. GUIDELINES on Good Clinical Practice Specific to Advanced Therapy Medicinal Products. Brussels, 10.10.2019. C(2019) 7140 Final.
Published by European Commission (EC)
Advanced TherapyGood Clinical PracticeEuropean Commission. GUIDELINES on Good Clinical Practice specific to Advanced Therapy Medicinal Products. Brussel
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