The AE/SAE Notification Tool can be set up to automatically notify you if your research subjects come in to many of the PHS Emergency Departments or are directly admitted to a hospital. The system covers PHS affiliated hospitals and reduces the amount of time to gather information about adverse events and reinforces subject safety. Designated study staff can be notified by email, page or phone 24/7. As part of the set up, a member of the study team must enter each subject's information into the system.
If investigators are interested in using this service, contact Keith Jennings at email@example.com with the following information:
Note: For ongoing studies, an amendment must be submitted to the IRB and the consent form updated to include information regarding use of the alert system.
Standard statement for ICFs (in gray instruction box in the Partners IRB General Consent Form template) which can be customized to your institution:
-PHS Alert System, include statement, "[Enter Institution] has an electronic system that lets your study doctors know if you are admitted to a Partners Hospital, or if you visit a Partners Hospital Emergency Department for any reason. This alert will let the study doctors know why you are there. We want to make sure the study doctors know about any possible problems or side effects you experience while you are taking part in the study."