University of Nevada, Reno
Research Integrity Office
Investigator Reporting Form
Researchers must report problems, incidents or situations; and submit sponsor reports to the Research
Integrity Office or IRB staff, as soon as possible, but within five business days of learning of the problem
or receiving the sponsor report. Check all that apply for a specific submission, and describe the
occurrence or the purpose and general conclusions in sponsor reports.
Date:
Principal Investigator:
Protocol Title:
UNR Protocol
Number:
Contact Person:
Sponsor:
New or additional risks: Outcomes that the principal investigator believes are unexpected, related to
the research, and suggest the research may place participants or others at greater risk of harm than
was previously known or recognized. Note: To report a local, serious adverse event, also complete
and submit form II1F F01.
Description or explanation:
Changes to expected harms or benefits: Any findings indicating the frequency or magnitude of
harms or benefits may be different than initially presented to the IRB.
Description or explanation:
Privacy: Any invasion of privacy related to an individual’s participation in research.
Description or explanation:
Confidentiality: Any breach of confidentiality involving research data.
Description or explanation:
FDA changes: Any change in FDA labeling or withdrawal from marketing of a drug, device, or biologic
used in a research protocol.
Description or explanation:
Immediate harm: Any change to the protocol to eliminate an apparent immediate hazard to a
research participant, prior to seeking IRB review and approval.
Description or explanation:
Prisoner: Any incarceration of a participant in a protocol not approved to enroll prisoners.
Description or explanation:
Report of local adverse event or problem: Any event or problem that occurred at the local site and
that requires prompt reporting to the sponsor. Note: To report a local, serious adverse event, also
complete and submit form II1F F01.
Description or explanation:
12/03/13
Page 1 of 2
Investigator Reporting Form
Sponsor: Any sponsor-imposed suspension for risk.
Description or explanation:
Sponsor: IND safety and DSMB/DSMC reports.
Description or explanation:
Protocol change: An accidental or unintentional change to the IRB-approved protocol that harmed
participants or others, indicates participants or others may be at increased risk of harm, or has the
potential to recur.
Description or explanation:
Device: Any unanticipated adverse device effect.
Description or explanation:
Department of Health: Any non-compliance identified by Department of Health audit or monitoring.
Description or explanation:
Federal agency: Any investigation or report by federal agency related to the research
Description or explanation:
Medical License or practice changes: Any loss of license or hospital privileges by any researcher on
the study.
Description or explanation:
Complaints: Any complaints that suggest participants/others may have been harmed or placed at
increased risk of harm.
Description or explanation:
IRB or IRB Staff: Problems with the IRB or IRB staff.
Description or explanation:
Other problem: Any other problem, situation or outcome that may affect research participants or
others, or the conduct of the research.
Description or explanation:
12/03/13
Page 2 of 2