Bontrop, Vincent Safety Reporting Flowchart: AE, SAE, SSAR, SUSAR <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> 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
    https://figshare.com/articles/figure/Safety_reporting_flowchart_AE_SAE_SSAR_SUSAR/1300177
10.6084/m9.figshare.1300177.v3