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 and diagnostics reports, etc)

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

  • Completion of MedWatch/CIOMS forms

  • Provision of Global Submission of SUSARs to regulatory agencies

Learn More with These Resources