Wichita State University Institutional Review Board (IRB)
RTT July 2015
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)
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:
Completed (or stopped)
c. Research interventions/interactions involving other participants are:
Completed (or stopped) for all participants
RTT July 2015
Describe in detail the event or problem being reported. Include all details such as the date(s) of event, number of events,
number of participants involved, known or potential impact on participants, and any other relevant information. Attach
additional documents as necessary. Do not include (and remove as necessary) participants’ personally
identifiable information.
Actions to be taken:
As a result of the event (check all that apply):
The protocol or study procedures will be modified.
The consent form or process will be modified.
Additional information and/or follow-up will be provided to current and/or past participants.
Current participants will be asked to re-consent to participation.
The research will be voluntarily placed on hold, pending more information or resolution of problem.
The research is being stopped.
No action is planned. Provide explanation below:
Other specify:
Provide the IRB Amendment form for all proposed changes.
PI Signature: Date:
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