Unanticipated Problems Involving Risk to Participants or Others

Reportable events must meet all three of the following criteria:

1.     Unanticipated or unexpected in nature, frequency or severity, AND

2.     Related or possibly related to participation in the research (there is a reasonable possibility that it is related), AND

3.     The event suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized (not already referenced in existing study documents, such as the protocol, consent form or Investigator’s Brochure)

Note:  For industry-sponsored studies, it is the responsibility of the sponsor or data safety monitoring board to assess events and to provide sufficient information to investigators to determine which events meet criteria as unanticipated problems involving risk to participants or others.