HOWTO: Insight > Biosafety > Serious Adverse Event (SAE) & Other Reports

Introduction 

Submit a Serious Adverse Event (SAE) report or a study pause using these steps.

 

STEPS 

  1. From an open clinical registration, click ‘Create SAE and other Reports’ under the Actions menu (this function only exists for clinical registrations)  

  1. Complete the required fields about the trial, report, and adverse event, and click Save 

  1. The attachments section unlocks when you complete the SAE, allowing users to upload documents, but you cannot edit existing documents. 

  1. After completing the steps above, click Submit.

 

Illustrative Screenshots  

Note: This option only exists for clinical studies 

Go to KB0045261 in the IS Service Desk