Unanticipated Problem Form
Unanticipated Problem Report Form
PI Name:
Project Title:
Local Event External Event (You must select 1)
Patient ID #:Type of Report: / Initial / Follow-Up / Previous Event # (if Follow-Up Report):
Background:
Protocol Involves an IDE for use of a device (all unexpected events probably related to a device must be reported)
Protocol Involves an IND for use of a drug/biologic
HDE (Humanitarian Use Device)
Participant is a veteran
Expectedness:
Expected
Unexpected
Risk: is related to the Type of Adverse Event/Occurrence or Problem Involving Risk
Check all that apply
Non-Compliance, such as over-enrollment, failure to meet exclusion/inclusion criteria at request of study monitor
Protocol Deviation
Complaint about research from subject or other investigators, etc.
Unanticipated problem that represents risk beyond that approved by the IRB
Problem involving data collection, data storage, privacy, or confidentiality
Unfavorable / Unintended serious medical finding (i.e. laboratory findings, symptoms, disease, syndrome, disability)
Serious / Untoward Adverse Psychological /Social Occurrence
Congenital anomaly or birth defect
Significant or additional therapeutic intervention was required
(i.e. new or prolonged hospitalization, emergency/urgent care, procedure to prevent adverse outcome)
DMC / DSMB / Other Safety Update report / New information relevant to the study
Unexpected Population Status Change (pregnancy, subject incarceration, other)
Other
Death (see below)
Death:
Death occurred within 30 days of intervention? / Yes No
If Yes: / Date:
Primary Cause:
Secondary Cause:
Relationship of Unanticipated Problem to Study:
Not all adverse events may involve treatement (e.g. risk involving confidentiality or psychological outcomes)
Select the ONE that best applies
Not Related
Unlikely Related / Possibly
Reasonable Probability it is Related / Probably
Definitely Related
Unknown
Not Applicable
Previous Reporting of similar Unanticipated Problems:
Has this type of event been reported previously to COMIRB? / Yes No / If yes, list the # of Times Local:
If yes, list the # of Times Off Site:
Is this event named in the consent form as a risk? / Yes No
If yes, Page #: / If No, Should it be named in the consent?
Yes No / If Yes, submit changes on Alteration/Update Form
If No above, please Justify not including in the consent:
Do you recommend Protocol Changes? / Yes No / If Yes, submit a Protocol Amendment Form
Accrual Information:
Total Number of LOCAL subjects Approved by COMIRB?
Current LOCAL Accrual?
Anticipated Target Accrual across all sites?
(Should be in the Protocol)
This is a Multi-Institutional Study
Timeline:
Date Event Started?
Date Event Ended/Resolved? / Event is ongoing (not resolved)
Date local PI/coordinator became aware of event?
Describe the Problem: (Include Dates and Sequence of Events)
Unanticipated Problems must be submitted within five (5) days of when the event started.
Type name of PI (or persons filing report*):Signature: / Date:
* PI is required to sign the Unanticipated Problem report. If PI will not be available within the 5 day mandatory reporting period, a Co-Investigator may file this report for the PI
Unanticipated Problem Report Form Page 3 of 3
CF-129, Effective 8-31-11