Event Reporting System

Login / Register - Click to Login / Register

Please be advised that as of February 1, 2006, the USF IRB has revised its policy regarding the reporting of adverse or unanticipated events. The USF IRB policy now states that only those events which meet the following criteria should be submitted, via this on-line system, for IRB review:

• Internal, related events or problems that are:
• Serious adverse events,
• Unanticipated/unexpected adverse events, or
• Unanticipated problems.
• Internal or external events or problems that:
• Require changing the protocol,
• Require changing the informed consent document, or
• Result in an administrative hold.

If an external adverse or unanticipated/unexpected event does not meet the above USF IRB policy for submission, then the event will not be accepted for consideration by the USF IRB.

Please do not submit any other types of external events to the USF IRB.

We have provided copies of the new USF IRB Policy and a letter (see below) which explain the USF IRB Policy on reporting adverse and unanticipated events that you can provide to your sponsor and/or interested third party, for your convenience:

• USF IRB Policy 212: Reporting Unanticipated Problems Involving Risks to Participants or Others
• Letter to sponsor or interested third Party

Start-up Materials
   :: Start-up Guide
   :: User License Agreement
   :: User Manual (MS Word)
   :: User Manual (PDF)
   :: Frequently Asked Questions (PDF)