10.6084/m9.figshare.1300177.v3 Vincent Bontrop Vincent Bontrop Safety Reporting Flowchart: AE, SAE, SSAR, SUSAR figshare 2015 adverse event adverse reaction serious adverse event susar safety reporting gcp ae sae sar ssar good clinical practice clinical trial eu European Union investigational medicinal product imp Clinical Research Medicine Health Care Pharmacology 2015-02-04 01:06:24 Figure https://figshare.com/articles/figure/Safety_reporting_flowchart_AE_SAE_SSAR_SUSAR/1300177 <p>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.</p>