VA TennesseeValley Healthcare System (626)

Institutional Review Board

Adverse Event/Problem Reporting Form

This form should be used for reporting adverse events, serious adverse events, and unanticipated problems and events involving risks to participants and others. Serious adverse events or unanticipated problems are to be reported to the IRB as soon as possible butno later than 5 business days upon discovery. Life-threateningevent and sentinel event (death) must be reportedimmediately. Note: The IRB Protocol Violation or Incident Reporting Form will be used for reporting of protocol deviations, protocol violations, and noncompliance issues.

Principal Investigator:

VA Responsible Investigator:

Study Title/RCMS ID #:

Date of This Report:

1) Type of Report:

Initial (first) Report of Event/Problem Follow-Up Report

2) Date of event/problem:

3) Occurrence: On Site Off Site

4) Date Principal Investigator notified of event/problem:

5) Participant Identifier: (Do not include any personal identifiers)

6) Describe the event/problem (e.g., describe the event to include hospitalizations):

7) In the opinion of the Principal Investigator, was the event/problem:

Expected: Yes No

Related: Yes No

Possibly Related: Yes No

Placed Participants or Others at Risk

YesDescribe the risk:

No Describe why there is/was no risk:

8) Describe the treatment or interventions provided and the resolution (this may include interventions to prevent future occurrence):

9) Does this study have a Data Safety Monitoring Committee/Board or Data Safety Monitor?

Yes No

If yes, has the event/problem been reported to the Data Safety Monitoring Committee/Board

or Data Safety Monitor?

Yes No Pending

If, yes please attach a copy of the Data Safety Monitoring Committee/Board or Data Safety

Monitor review.

8) Has the sponsor been notified of the event/problem?

Yes No Non-applicable/not-sponsored

If no, please explain.

If yes, please include the date the sponsor notified and attach a copy of the sponsor's

response, if available.

9) In your opinion, does this event/problem change the risk/benefit relationship or place participants or others at increased risk of harm or discomfort?

Yes No

10) In your opinion, are changes to the protocol or informed consent document warranted as a result of this event/problem?

Yes No

If yes, attach an amendment outlining the revisions to the protocol and/or revised consent form. Please provide one copy of the consent form with changes tracked and one clean copy.

► Attach a copy of ALL reports related to this event.
► Attach continuation pages as needed to fully explain any item
As the Principal Investigator, I certify that I have personally reviewed the attached event/problem report.
Yes No(If no, please explain.
Signature: Date:
IRB Chairperson Use only
IRB Chairperson/Designee Determination:
1) Yes No The information in this report is unanticipated.
2) Yes No The information in this report is serious.
Yes No The information in this report is related or possibly related.
Yes No The information in this report indicates that participants or
others are at increased risk or harm.
No immediate action is required. Refer to full IRB Committee for review.
Immediate action is required to prevent an immediate hazard to participants. Refer to full IRB
Committee for review.
If Yes to Items 1-3, refer to the IRB Chairperson for reporting to the Facility Director as soon as
possible but not later than 5 working days after determination.
No further action is required under the Procedure for Unanticipated Problem
Involving Risks to Participants and Others.
Comments:
Signature: Date:

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Adverse Event/Problem Report Form/Version 06302009