Safety Adverse Event (SAE) Management
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Triage of all initial and follow-up source documentation to ensure criteria for a reportable case(s) are met and review for accuracy and completeness
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Assignment of case numbers to all new SAEs
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Obtaining the causality assessment from the medical monitor within 24 hours
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Communication with site(s) to obtain all supporting documentation (ex. Discharge summaries, autopsy reports and diagnostics reports, etc)
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Drafting of safety narrative(s) according to ICH guidance encompassing relevant information and query the site for additional information
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Completion of MedWatch/CIOMS forms
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Provision of Global Submission of SUSARs to regulatory agencies
