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Guideline for good clinical practice E6(R2): https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic): https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-content-management-archiving-clinical-trial-master-file ...
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