Wichita State University Institutional Review Board (IRB)
RTT July 2015
EVENT REPORTING
For Unanticipated Problems Involving Risks To Subjects or Others,
Adverse Events, and Other Problems
IRB Number: Date of Report:
Study Title:
Name of Principal Investigator(s):
E-Mail Address: Phone:
Department/Program Affiliation:
Type of Report
Adverse device effect (Report only if unanticipated.)
Adverse event or injury (Report only if serious, unexpected, and related.)
Breach of confidentiality
Data and Safety Monitoring Board (DSMB) report, interim analysis, or other oversight committee/monitoring report
Investigator’s brochure update
New information (Report information indicating an unexpected change in risks or potential benefits, e.g.,
literature/scientific report or other published finding.)
Protocol deviation, violation, or unintentional change to protocol or procedures
Subject complaint (Report complaints indicating unanticipated risks.)
Unapproved change made to the research to eliminate an apparent immediate hazard
Other problem or finding (e.g., loss of study data, a subject becomes a prisoner while participating in research) –
specify:
Research Status
a. The research participant(s) involved is/are:
Still in the study
No longer in the study
N/A or unknown
b. Research recruitment is:
Ongoing
Completed (or stopped)
c. Research interventions/interactions involving other participants are:
Ongoing
Completed (or stopped) for all participants