ADVERSE EVENT REPORTING FORM SECTION I INSTRUCTIONS FORMS

Definitions 100 Series Avoid Adverse Impacts Means to
0 REPORT ON ADVERSE DRUG REACTION 1 REPORTER (DOCTOR
A DVERSE EVENT NOTIFICATION FORM CHAPTER 7056 ADVERSE HEALTH

ADVERSE EVENT (AE) REPORTING FORM INSTITUTIONAL REVIEW BOARD (IRB)
ADVERSE EVENT FORM STUDY NAME SITE NUMBER PTID
ADVERSE EVENT REPORT SGU IRB APPLICATION REFERENCE ADVERSE EVENT

IRB Adverse Event Reporting

Adverse Event
Reporting Form

Section I: Instructions

Forms must be typed and all sections completed. Note: If any sections are incomplete, the form may be returned to you.
The Expedited Reporting Form for Unanticipated Problems and Noncompliance (0203) must be completed and attached, for initial reports as well as for follow-up reports.
The current consent document(s) must be attached.

This adverse event is being reported to the IRB because it was (1) unexpected, and (2) related or possibly related to the research, and (3) serious or suggests that the research places research participants or others at a greater risk of physical or psychological harm than was previously known or recognized OR the protocol required expedited reporting per IRB Policy 2.6 Unanticipated Problems Involving Risks to Subjects and Others (0224) and IRB Policy 1.11 Reporting Obligations for Principal Investigators (032). Please check all boxes that apply:

The adverse event was Unexpected

and

The adverse event was Related or Possibly Related to the research

and

The adverse event was Serious or placed research participants or others at a greater risk of physical or psychological harm than was previously known or recognized.

The Protocol or Sponsor required expedited reporting to the IRB.

Section II: Investigator and Research Study Information

IR File#:	Protocol #:		Date of Report:
Principal Investigator:

Is this study being conducted under an IND/IDE?		Yes No If yes, complete the following:
		Name of Drug/Device/Biologic:
		IND/IDE Number:
		Holder of the IND/IDE Number:
		Location of IND/IDE Holder:

Section III: Event Information

Subject ID or UPN: (do not list research participant names or initials):
Gender	Male Female	Age:
Event Start Date:		Event End Date:

Specific Adverse Event: (example: Cardiac Arrest)

Adverse Event (provide a brief summary describing the signs, symptoms, or diagnosis, if appropriate):

Type of Report

1. Has this event been previously reported to the IRB?

Yes  Follow-up #:

No  This is an initial report.

2. Is on-going follow-up necessary?

Yes  I will submit a follow-up report to the IRB every 30 days.

No  This is a final report.

Section IV: Severity

Brief Description of The Event (Attach Additional Sheet If Needed)
(Check only those that apply)

The following categories fall under the reporting requirements and should be reported accordingly:

1. Outcomes attributed to adverse event (Check all that apply).

Death / /	Disability
Life-threatening	Congenital anomaly or birth defect
Required hospitalization	Prolonged hospitalization
Required intervention to prevent one of the above outcomes

Does the event result in an increased risk to research participants or others?

Yes

Does the event affect the rights, safety or welfare of the research participants or others?

Yes

Does the event affect the integrity of the study?

Yes

Has the adverse event been reported to all appropriate agencies as defined in the protocol, grant, contract, or Clinical Research Agreement?

No  Please explain:

N/A

Yes  Check all that apply:

DSMB

Sponsor  Please name the Sponsor(s):

FDA (If Fred Hutch/UW PI holds the IND/IDE)

Coordinating Center

Other Regulatory Agencies  Specify:

Is this adverse event currently described in the informed consent document and/or protocol?

No  Please explain:

Yes  On what page is the event described?		Page #:

040IRBform_AE_Reporting / Version 5.00 / 01-21-2019 / Page 3 of 3

ADVERSE EVENT REPORTING FORM SECTION I INSTRUCTIONS FORMS
ADVERSE EVENT SUMMARY V 50 N (INCLUDE NUMBER
ADVERSE EVENT TRACKING LOG STUDY TITLE PRINCIPAL INVESTIGATOR STUDY

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