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.