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IRB#:

Date of this Report:

Principal Investigator:

Study Title:

Vanderbilt University Institutional Review Board

Report of Adverse Events and Unanticipated Problems Involving

Risk to Participants or Others

*Adverse events, and/or unanticipated problems involving risks to participants or others may be reported to

the IRB by anyone. It does not require the signature of the Principal Investigator.

NOTE: If a MedWatch Report (FDA Form 3500) has been submitted to the FDA, please attach it to this report

and skip questions 4-10. Check here if MedWatch Report is attached:

1. Describe type of event:

Event that requires prompt reporting to the sponsor in accordance with the protocol (e.g., serious adverse

events);

Accidental or unintentional change to the IRB-approved protocol that involves risks or has the potential to recur;

Deviation from the protocol taken without prior IRB review to eliminate apparent immediate hazard to a research

participant;

Publication in the literature, safety monitoring report including a Data and Safety Monitoring Report, interim

result, or other finding that indicates an unexpected change to the risk-potential benefit profile of the research;

Adverse event that is both a serious adverse event and an unexpected adverse event, which in the

Investigator’s opinion is more likely than not to be related to the research procedures;

Breech in confidentiality that may involve risk to that individual or others;

Complaint of a participant that indicates an unanticipated risk or which cannot be resolved by the research staff;

Other event that is unanticipated, involved risk to participants or others and was possibly related to the research

procedures.

(Note: Events that do not fit into the above categories do not require reporting to the IRB. However, the event may

require reporting to the sponsor or data monitoring plan.)

2. In the opinion of the Principal Investigator, was this event:

Unanticipated?

Yes

No (An event is “unanticipated” when it was unforeseeable at the time its occurrence)

Serious?

Yes

No (An event is “serious” if it adversely alters the risk/benefit relationship of the research)

Related?

Yes

No (An event is “related” if it is Likely to have been caused by the research procedures)

3. Please indicate type of report:

Initial (first) Report of Event/Problem

Follow-Up Report (report #

)

4. Date of Event/Problem:

5. Participant Identifier:

(DO NOT include a name OR ANY personal identifiers)

6. Participant Age:

7. Identify Drug/Biologic/Device/Treatment/Intervention (if applicable):

8. List 3 – 4 keywords describing the event/problem (e.g., loss of confidentiality, nausea and vomiting):

Report of Unanticipated Problems (Form #1105)

1 of 3

Form Revision Date: November 16, 2010

Replaces Form Dated: August 22, 2006

Report Of Adverse Events And Unanticipated Problems Involving Risk To Participants Or Others - Vanderbilt University

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