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EMEA. VICH Topic GL9 (GCP) (2000) Guideline on Good Clinical Practices. The European Agency for the Evaluation of Medicinal Products (EMWA/CVMP/VICH/ 595/98-Final).
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/
WC500004343.pdf

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