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

#

/

QUESTION

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INVESTIGATOR’S RESPONSE

1 / GENERAL INFORMATION
1.1 /

IRB #:

1.2 /

Date of Report:

1.3 /

Check one of the following:

/ Initial Report Follow-Up Report
1.4 /

Name of Principal Investigator:

1.5 /

Protocol Title:

2 / EVENT INFORMATION
2.1 / Is the event Local or Non-Local? / Local Non-Local
2.2 / 2.2.1 Relationship of adverse event to test article or study intervention:
If Unlikely or Unrelated, this event does not need to be reportedand this form does not need to be completed. / Definite – clearly related to the research
Probable – likely related to the research
Possible – may be related to the research
Unlikely – doubtfully related to the research, or
Unrelated – clearly not related to the research
2.2.2 If event occurredonaprotocol other than that listed above in 1.5, does sponsor require reporting event to this IRB? / Yes. This event does not need to be individually reported. A summary may be prepared at the time of continuing review along with all other related events not individually reported.
No. No need to report
Not applicable; event occurred on this protocol.
2.2.3 Is event an unexpected adverse drug experience or anunanticipatedadverse device effect? / Yes.
1. If event involves a drug, see 2.2.4 below.
2. If event involves a device, complete this form and the “ABHN Unanticipated Problems” form.
No. If no, this event does not need to be individually reported. A summary must be included at the time for continuing review along with all other related events not individually reported.
2.2.4 Is this drug event serious? / Yes.
1.Complete this form.
2. If drug event is local, also complete the “ABHN Unanticipated Problems” form.
No. If no, this event does not need to be individually reported. A summary must be included at the time for continuing review along with all other related events not individually reported.
2.3 /

Participant’s ID #:

2.4 /

Age:

2.5 /

Sex:

/ Male Female
2.6 / Research involved the use of an investigational: / Drug/biological Device Procedure
2.7 /

Date of onset of Event:

2.8 /

Date event reported to PI:

2.9 /

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

/ ___minutes, ___hours, ___days, ___months, ___years
not applicable, no test article administered
2.10 /

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

3 / OUTCOME OF EVENT
3.1 / Do you expect this event to occur again? / Yes / No
3.2 / Is the risk of the event adequately described in the protocol and consent form? / Yes / No
3.3 / Should (or has) the protocol be(en) modified to protect future subjects?
If yes, please send the changes under separate cover as an amendment. / Yes / No
3.4 / Should (or has) the consent formbe(en) modified as a result of this adverse event?
If yes, please send the changes under separate cover as an amendment. / Yes / No
3.5 / Do you or the sponsor recommend that current subjects be re-consented or provided additional information as a result of this adverse event? / Yes / No
3.6 / Do you or the sponsor recommend providing additional information to past participants? / Yes / No
Signature of PI: ______Date: ______

10-23-08

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