Safety Reporting Flowchart: AE, SAE, SSAR, SUSAR
Vincent Bontrop
10.6084/m9.figshare.1300177.v3
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>
2015-02-04 01:06:24
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