Safety Adverse Event (SAE) Management

 

  • 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

  • Assignment of case numbers to all new SAEs

  • Obtaining the causality assessment from the medical monitor within 24 hours

  • Communication with site(s) to obtain all supporting documentation (ex. Discharge summaries, autopsy reports, laboratory and diagnostics reports, etc)

  • Drafting of safety narrative(s) according to ICH guidance encompassing medically relevant information and query the site for additional or discrepant information

  • Completion of MedWatch/CIOMS forms

  • Provision of Global Submission of SUSARs to regulatory agencies

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