Report Protocol Changes or Adverse Events

Protocol Changes

Approval is granted on the condition that any deviation from the protocol will be submitted for separate approval in the eIRB System.

Adverse Events

Any adverse event(s) or unexpected events(s) that occur in conjunction with this study must be reported to the IRB at (irb@tcnj.edu.) and to the Risk Management Officer (bwebb@tcnj.edu) immediately.

Please review Sample Documents for an example of an Adverse Events Report.