Submitting an Adverse Event (AE) Report in e-Protocol

  • To report an adverse event, go to the e-Protocol website and login.
     
  • From the main screen, click on Approved Protocols in the menu on the bottom left of the screen.
  • Click on the protocol number for which you wish to submit the report.
  • A window will open with several options.
  • Click the circle beside Start Adverse Event Report .
  • The protocol will open with an adverse event form. Fill out all of the information on the form.
  • If your adverse event requires changes to the informed consent document, attach the revised document.
  • Check that all information has been entered by clicking on Check for Completeness in the menu on the left. When you are ready to submit your form, click on Submit Form in the menu on the left.
  • Once the adverse event report is submitted, the protocol will appear in two places within your account. The originally approved protocol will appear under Approved Protocols. The adverse event report will appear with the same protocol ID on the main page of your account, with the Protocol Event as Submitted .
  • All future correspondence regarding the adverse event report will have the original protocol ID number, followed by [Report].
  • Once the adverse event report has been reviewed by the IRB, you will receive an email stating the decision of the IRB. If changes need to be made to the protocol, you will need to login to e-Protocol and open the appropriate protocol for editing, by clicking on the item listed for that protocol under Protocol Event . Within this protocol you will find comments from the reviewers and/or the IRB staff. You must make all recommended changes and re-submit the protocol.