IRB Adverse Event Reporting

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

No

Yes

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

No

Yes

  1. Does the event affect the integrity of the study?

No

Yes

  1. 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:

  1. 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 1 of 3

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