IRB#:
Date of this Report:
Principal Investigator:
Study Title:
Abington Memorial Hospital Institutional Review Board
Report of Adverse Events and Unanticipated Problems Involving
Risk to Participants or Others
*Protocol deviations, violations, 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)
Form Revision Date: August 22, 2006
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)
IRB#:
Date of this Report:
Principal Investigator:
Study Title:
9. Event/Problem Description: Provide a description of the event/problem including the timing of study treatment, dosing,
or intervention with start and stop dates of relevant research interventions.
10. This study (choose one):
has a Data Safety Monitoring Committee/Board (DSMC/DSMB) or Data Safety Monitor (DSM) (if yes, choose one):
a copy of the DSMC, DSMB, or DSM’s review of the event/problem is attached
the DSMC, DSMB, or DSM has not reviewed the event/problem
the DSMC, DSMB, or DSM review is pending
does not have a Data Safety Monitoring Committee/Board or Data Safety Monitor (DSM)
11. This Event/Problem is (choose one of the following):
Currently described as a risk in the informed consent document and does not require submission of an
amendment.
Not listed as a risk in the informed consent document and submission of an amendment is not recommended at
this time. Please explain:
Not listed as a risk in the informed consent document and requires submission of an amendment.
12. Has the PI been notified of this Event/Problem and received a copy of this report? The PI should be
notified of all protocol deviations, protocol violations, adverse events, and/or unanticipated problems involving
risks to participants or others. The PI is responsible for the accurate documentation, investigation and follow-up
of all protocol deviations, protocol violations, adverse events and/or unanticipated problems involving risks to
participants or others that are possibly related to study participation.
Yes
No
13. Has this Event/Problem been reported to the Sponsor?
Yes
No If “No”, please provide rationale for not reporting:
14. Sponsor’s response (if applicable).
15. Additional Comments:
________________________________________________
________________
Principal Investigator’s Signature
Date
_____________________________________________________
*Other Signature
__________________
Date
__________________________________________________
Role in Study
(For IRB Chair Use Only)
IRB Sub-Committee Review
Report of Unanticipated Problems (Form #1105)
Form Revision Date: August 22, 2006
Full IRB Committee Review
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