Safety Reporting Flowchart: SUSAR, SAE and SSAR Expedited Reporting flow
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Safety Reporting Flowchart: SUSAR, SAE and SSAR Expedited Reporting flow. The texts are derived from the European Clinical Trial Directive 2001/20/EC and the ICH Harmonised Tripartite Guideline Good Clinical Practice (CPMP/ICH/135/95). If necessary (e.g. readability) content was modified for instructional and educational purposes.