The updated version “Guideline on computerised systems and electronic data in clinical trials” will be effectivce September 2023. Keywords: Computerised systems, electronic data, validation, audit trail, usermanagement, security, electronic clinical outcome assessment(eCOA), interactive response technology (IRT), case report form(CRF), electronic signatures, artificial intelligence (AI) 6.7. Cloud solutionsIrrespective whether a computerised system is installed at the…

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