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Safety Reporting Flowchart: AE, SAE, SSAR, SUSAR

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posted on 04.02.2015 by Vincent Bontrop

Safety Reporting Flowchart: AE, SAE, SSAR, SUSAR. The texts are derived from the European Clinical Trial Directive 2001/20/EC, the detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3′) (2011/C 172/01) and the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95). If necessary (e.g. readability) content was modified for instructional and educational purposes.