Expedited Reporting Form
for Unanticipated Problems
or Noncompliance
IR file#
Date:
This box is for IRO only
Date Received:
Protocol#:
Principal
Investigator:
PI Mailstop Phone:
Contact
Person:
Contact
Mailstop/Phone:
Study
Title:
Date PI/study
staff became
aware of this
event:
1.
Person filling
out report:
Date of Report:
Provide a summary of the event in the box below. Use lay terminology when summarizing the event.
Include at a minimum the date of event, date of discovery, summary of the event, and the
outcome/resolution. If this is a follow-up report, also provide a brief summary of any earlier reports,
and the dates they were submitted to the IRB. Additional details may be attached in a separate
memo or report if necessary; however, a summary description must be provided in question 1.
1.a. Where did this event occur? (e.g., FHCRC, SCCA, UW Medicine, etc.)
1.b. Did the event involve the UW/SCCA Investigational Drug Service (IDS) Pharmacy?
No
Yes  Please provide the date the IDS Pharmacy Director was notified of this event.
This box is for IRO only
Reviewing Committee (Reg ID):  A (0021)  B (0022)  C (5619)  D (9831)
Agenda Date:
Assurance #: FWA00001920
Review Type:
 Full Committee
_____________
 Expedited Reviewer Only
IRB Determination:
 Event does constitute  serious noncompliance,  continuing noncompliance, and/or  an unanticipated
problem involving risks to subjects or others. Outside agencies and institutional officials will be notified per
institutional policy. Corrective action plan is appropriate. The Committee requires no further action at this time.
 Event acknowledged. Event does not constitute serious or continuing noncompliance or an unanticipated problem
involving risk to subjects or others. Reporting to outside agencies not required. The Committee requires no further
action at this time.
Approval Signature, Chair or Designee
Date
Printed Name
For “Expedited” transactions, the “Agenda Date” above is the date the expedited approval gets reported to the convened IRB.
0203IRBForm_ExpeditedReporting / Version 3.00 / 08-01-16 / Page 1 of 4
1.c. Are you aware of any similar event(s) in this research?
No
Yes  Please describe the similar event(s). Include details regarding how often this type of
event has been reported previously and whether you consider the frequency to be
unusually high.
1.d. In the PI’s opinion this event may constitute the following: (Check the most applicable option.)
For additional information and definitions see IRB Policy 1.11 Reporting Obligations for Principal
Investigators.
Unanticipated Problem involving risks to subjects or others
Serious Noncompliance
Continuing Noncompliance
None of the above  Explain why the event is being reported (e.g., sponsor’s requirement to
submit an expedited report to IRB):
2.
Is this event being reported as a potential Unanticipated Problems Involving Risks to Subjects or
Others?
No
Yes  Check the applicable checkbox categorizing the unanticipated event:
Biomedical Adverse Event occurring locally that was unexpected, related or possibly related,
and serious or suggest the participant is at increased risk  submit a completed Adverse
Event Reporting Form and a copy of the current consent form.
The protocol or sponsor requires expedited reporting of this event to the IRB even though in
the PI’s opinion the event does not satisfy the requirements for expedited reporting 
submit a completed Adverse Event Reporting Form and a copy of the current consent form.
3rd Party Safety Report that satisfies the Expedited Reporting requirements for Unanticipated
Problems  submit a completed 3rd Party Safety Reporting Form and a copy of the current
consent form.
Other Unanticipated Problem involving risks to subjects or others  please submit a copy of
the current consent document(s).
3.
Is this event being reported as Noncompliance?
No
Yes  Check the applicable checkbox categorizing the noncompliance event:
Failing to obtain prospective IRB approval of human subjects research.
0203IRBForm_ExpeditedReporting / Version 3.00 / 08-01-16 / Page 2 of 4
Enrolling research participants who do not fit the inclusion and exclusion criteria in the
protocol.
Failing to obtain or document informed consent.
Administering a drug at a dose that has not been approved by the IRB.
Administering a drug at a schedule that has not been approved by the IRB.
Other noncompliance event which
could constitute serious or continuing
noncompliance, describe 
4.
Action(s) that will or may be taken as a result of the event: Check all that apply and describe below:
A change to the consent/assent form, protocol or other information provided to
research participants
If this box is checked, submit a Research Modification Form. Include one (1) track change and
one (1) clean version of each modified document. If this is a study managed by Clinical Research
Support (CRS), please provide the date you submitted the Research Modification form to CRS.
Date submitted:
Re-consenting or notifying research participant
If this box is checked and you will be using materials not previously approved by the IRB, submit
a Research Modification Form to describe the plan and include the letter or communication to
participants. If this is a study managed by Clinical Research Support (CRS), please provide the
date you submitted the Research Modification form to CRS.
Date submitted:
5.
Please describe your plan of action to prevent a similar event in the future.
6.
Is this event being reported within 10 calendar days of the PI or study staff becoming aware of the
event?
Yes
No  Provide an explanation for why the event was not reported to the IRB in a timely manner.
0203IRBForm_ExpeditedReporting / Version 3.00 / 08-01-16 / Page 3 of 4
INVESTIGATOR STATEMENT AND SIGNATURE
NOTE: Only the Principal Investigator or designee listed in this IRB File can sign form. When
submitting this report to the IRB, please include a copy of the current consent document(s) and/or any
other applicable documents (e.g., protocol, protocol instructions brochures) for the study.
Typed (print) Name
Signature of Investigator
0203IRBForm_ExpeditedReporting / Version 3.00 / 08-01-16 / Page 4 of 4
Date