DAIDS Adverse Experience Reporting System (DAERS) Submitting EAEs Frequently Asked Questions

Once you have submitted the EAE, you cannot change the PID that was selected. However, if you have not yet submitted the Initial EAE (i.e., the status of the EAE report is either “Pending” or “Ready for Final Review”), you are able to correct the PID on the Patient Information screen.

• If you have submitted an EAE with the wrong PID, you must e-mail RSC (DAIDSRSCSafetyOffice@tech-res.com) to request a withdrawal of the EAE. Once the RSC accepts your requests, the EAE will be withdrawn and will no longer be considered an official EAE. You will need to enter a new EAE with the correct PID.
• If the EAE with the wrong PID has not been submitted, you are able to correct the PID on the Patient Information screen by typing in the correct PID and clicking “Change PID.”

Yes, the RSC will accept EAEs via e-mail or fax at 1-301-897-1710 using the old paper form or the printed out DAERS EAE form. It is highly encouraged that site staff complete the necessary steps to obtain access to the DAERS system and complete EAE through DAERS.

There are 2 ways to add recipients to receive EAE notifications automatically:

1. A Submitter can type the recipients’ e-mail(s) in the text box on the Submit EAE screen; a pop up box will allow him to add the recipients’ name(s) and designate whether they should continue to receive EAE notifications for the protocol and site. Once saved, the recipient’s name will be pre-populated on the Submit screen each time an EAE is submitted for the site and protocol.
2. The CRS Leader or CRS Coordinator can use the EAE Notifications Recipients Module to add or edit recipients for all sites and protocols to which they have access.