SafetyReportingFlowchart-AE_SAE_SSAR_SUSAR_flow.png (346.38 kB)
Safety Reporting Flowchart: AE, SAE, SSAR, SUSAR
Version 3 2015-02-04, 01:06
Version 2 2015-02-04, 01:06
Version 1 2015-02-03, 23:22
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posted on 2015-02-04, 01:06 authored by Vincent BontropVincent BontropSafety 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.