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Safety Reporting Flowchart: SUSAR, SAE and SSAR Expedited Reporting flow

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Version 3 2015-02-04, 01:07
Version 2 2015-02-04, 01:07
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posted on 2015-02-04, 01:07 authored by Vincent BontropVincent Bontrop

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.

 

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    gcpsarEuropean UnionClinical Researchexpedited reportingsafety reportingserious adverse reactionserious adverse eventsusarsaessarinvestigational medicinal productgood clinical practiceMedicineHealth CarePharmacology

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