The Emergency Use of An

AlexianBrothersHospital Network

Institutional Review Board

ADVERSE EVENT REPORTING INSTRUCTIONS

For Drug/Biological Studies:

• Any adverse drug/biological experience that is serious, unexpected, and related or possibly relatedto the investigational item must be reported to the IRB within 15 working days after the investigator first learns of the event.

• Anyunexpected fatal or life-threatening adverse drug/biological experiencethat isrelated or possibly related to the investigational item must be reported to the IRB within 7 working days after the investigator first learns of the event.

For Device Studies:

• Any unanticipated adverse device effect must be reported to the IRB within 10 working days after the investigator first learns of the event.

Definitions:

1. Life-threatening Adverse Experience: Any adverse experience that places the subject, in the view of the investigator, at immediate risk of death from the reaction that has occurred (i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death).
2. Serious Adverse Experience: Any adverse drug/biological experience occurring at any dose that results in any of the following outcomes: death; a threat to life; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
3. Unanticipated Adverse Device Effect: Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the protocol, instructions for use, or consent form, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
4. Unexpected Adverse Drug Experience: Any adverse drug/biological experience for which the specificity or severity is not consistent with any of the following: investigator brochure; protocol; risk information of the consent form.
5. Not related/Unlikely related: An adverse event that is not, or is unlikely to be, caused by or associated with the study, study drug/device or procedure, e.g., injury or death from an automobile accident.
6. Probably, possibly related: An adverse event for which there is reasonable probability or possibility that it was caused by the study drug, device or intervention, however there is insufficient information to determine the likelihood of this probability/possibility.

For all individually reportable adverse events (as defined above), complete the attached Adverse Event Reporting Form and return it to the IRB Administrative Coordinator. Please attach any Med-Alert, FDA Reporting Forms or any backup documentation to this document for submission.

ADVERSE EVENT REPORTING FORM

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QUESTION

INVESTIGATOR’S RESPONSE

IRB #:

Date of Report:

Check one of the following:

Name of Principal Investigator:

Protocol Title:

Participant’s ID #:

Age:

Sex:

Date of onset of Event:

Date event reported to PI:

Estimated time from test article administration to event onset time/date:

Describe the adverse event. Please include where it occurred, actions taken and patient outcome in the analysis. Use additional pages as necessary.

Signature of PI: ______Date: ______

10-23-08

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