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ENCePP Guide on Methodological Standards in Pharmacoepidemiology


13.3.Quality management in clinical trials

Rules, procedures, roles and responsibilities of quality assurance and quality control for clinical trials and biomedical research are well defined and described in many documents, such as the ICH E6 (R2) Good clinical practice, the European Forum for Good Clinical Practice (EFCGP) Guidelines, the Imperial College Academic Health Science Centre (AHSC)’s Quality Control and Quality Assurance SOP or the article Quality by Design in Clinical Trials: A Collaborative Pilot With FDA (Ther Innov Regul Sci. 2013; 47(2):161-6).



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