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Clinical Development Resources

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How to Handle Study Emergency SOP Considerations

While you are developing your site's SOPs on how to handle a study emergency, you should keep the following in mind:

  • When the site is made aware of a subject emergency the Principal Investigator and appropriate study coordinator should be notified.
  • The site should attempt to obtain all details of the emergency that are known at that time.
  • The site will refer to the protocol for any reporting guidelines to consider what might be required by the sponsor.
  • If the emergency is considered a serious adverse event (SAE) it should be reported to the sponsor and institutional review board (IRB), as required.