Missing SUSAR Documentation Highlighted During Safety Audits
Missing SUSAR Documentation Highlighted During Safety Audits Why Missing SUSAR Documentation Remains a Critical Audit Finding Introduction: The Role of SUSAR Documentation in Clinical Trials Suspected Unexpected Serious Adverse Reactions (SUSARs) represent one of the most significant aspects of clinical trial safety oversight. Regulatory agencies such as the FDA, EMA, and MHRA require timely reporting…
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