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Report Of Adverse Events And Unanticipated Problems Involving Risk To Participants Or Others - Vanderbilt University Page 2

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 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 adverse events and/or

unanticipated problems involving risks to participants or others that are possibly related to study participation.

Yes

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

Report of Unanticipated Problems (Form #1105)

2 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 Page 2