Internal Adverse Event and Unanticipated Problem Form

Institutional Review Board

(734) 712-5470

http://www.stjoesannarbor.org/irb

Internal Adverse Event and Unanticipated Problem Form

·  All deaths that are unexpected; internal; and possibly, probably or definitely related to intervention- notify IRB within 24 hours of knowledge of event and submit this form to the IRB within 5 business days of knowledge of the event.

·  Deaths that are anticipated or unrelated (i.e., due to anticipated disease progression) should be reported either a) at continuing review via the continuing review report (not this form) or b) via this form if the death was within 30 days of the study intervention and the sponsor requires that this be reported immediately to the IRB.

·  All other adverse events and unanticipated problems that require reporting should be submitted via this form to the IRB within 3 days of the knowledge of the internal event and within 10 days of knowledge for device study event that is not fatal (see IRB policy: Adverse events and unanticipated problems reporting).

Title of study:
IRB assigned #: / Local PI's name:
Date of event: / Date reported to the IRB (via e-mail to the Research Compliance Dept. or date in Credit):
Date researchers
learned of event:
1.  Briefly describe the event:
2.  This event is: / unanticipated in nature, severity, or frequency
anticipated
3.  Intensity (check all that apply)
serious/non-life threatening
life threatening
fatal
suggests greater risk of harm than known (OHRP-regulated studies) /

List the patient identifier/code (required for IRB response letter):

4.  Relationship to study intervention
possibly
probably
definitely
unrelated—stop: only submit signed form if this is required by sponsor
associated with the device / State rationale for relationship to study intervention:
5.  Treatment given or action taken:
none
medication
hospitalization (new or prolonged)
procedure or surgery
other / Provide details:
6.  Is the study open to accrual? / Yes
No
7.  Are there any participants receiving active study treatment or study intervention at SJMHS or affiliated institutions? / Yes
No
8.  Is this adverse event listed in the current IRB approved informed consent?
Yes- go to next question
No – answer to the right / Is a change to the consent form needed?
Yes - attach consent with changes
No - state the rationale for not needing changes (isolated event, pre-existing condition, etc.):
9.  Describe any other changes or corrective actions taken/to be taken by PI in response to the event (beyond answer to #5): / Any proposed changes to a research study must be approved by the IRB before being implemented, except when necessary to eliminate apparent immediate hazards to participants.
Describe: None

Local Principal Investigator’s Signature: ______Date:

Form version: 8/2016 1