1.STUDY INFORMATION

Principal Investigator: / Telephone Contact #:
IRB Protocol #:
Study Title:

2.EVENT INFORMATION

Subject Study ID (do not use names):
Event Site: Internal (NSMC) External (non-NSMC)
Event Report: Initial Follow-Up#
Date of Event:
Date local PI notified or became aware of Event:
Event Description:
Provide a brief description of the adverse event/problem (when applicable include name of study drug or device, dosing regimen, date subject received first and last dose of drug, date device used/implanted, date of intervention for other research interventions, medical history and/or concomitant medications) and resolution of event/problem. If applicable, please attach Sponsor Safety Report to this form.
  1. PRINCIPAL INVESTIGATOR’S ASSESSMENT OF EVENT

3.1Is the event Serious?

/ Yes / No
Serious unanticipated problems are those incidents, experiences, or outcomes that place subjects at increased risk of serious physical or psychological harm:
  • Events that result in death;
  • A life-threatening experience;
  • Inpatient hospitalization or prolongation of hospitalization;
  • Disability or incapacity;
  • Congenital anomaly/birth defect;
  • Or any other event that may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of these outcomes;
Or any significant economic or social harm (e.g., events that result in criminal or civil liability, damage to financial standing, employability, insurability, reputation, or are stigmatizing).

3.2Is the event Unexpected?

/ Yes / No
Note: In general, the event is unexpected if it is not consistent with (1) the known or foreseeable adverse events associated with the procedures involved in the research that are described in (a) the protocol-related documents, such as the IRB-approved research protocol, any applicable investigator brochure, and the current IRB-approved informed consent document, and (b) other sources of information, such as product labeling and package inserts; or (2) the natural progression of the underlying disease, disorder, or condition of the subject and the subject’s predisposing risk factor profile for the adverse event.
3.3Is the event more likely than not related to participation in the research or, in other words, is there a >50% likelihood of the event having been caused by the procedures involved in the research? / Yes / No
Explain:
3.4Does the event suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized?
Explain: / Yes / No
Reporting Requirements: Report ONLY those events as described below:
INTERNAL EVENTS:
  • Serious (3.1) and unexpected (3.2), regardless of relationship to the research
  • Unexpected (3.2), at least possiblyrelated to the research (3.3) and indicate there are new or increased risks to subjects (3.4)
EXTERNAL EVENTS:
  • Serious (3.1), unexpected (3.2), at least possibly related to the research (3.3) AND event indicates there are new or increased risks to subject(3.4) that require some action (e.g., modification of the protocol, consent process, informing subjects, etc.)

Timeframe for Reporting:
All events that meet the criteria for reporting must be submitted to the NSMC IRB within 5 working days/7 calendar days of the date the Investigator first becomes aware of the event.

4.CORRECTIVE ACTIONS

4.1Will the protocol or consent be revised or other corrective action(s) be implemented? (**Required for reporting of external events**)
.
  1. If Yes,
Protocol Amendment: submitted forthcoming NA
Consent Amendment: submitted forthcoming NA
Proposed Corrective Action:

FOR EXTERNAL EVENTS ONLY:

  1. If No,
    Provide justification why revision to the study documents or other corrective action is not required:
/ Yes / No
4.2Should currently enrolled subjects be notified of this event? TBD / Yes / No
If Yes, submit an amendment form with method or plan for notification
(e.g., letter) and description of the plan.
4.3Indicate if this event has been reported to any of the below (as applicable):
i. Patient Safety Event Reporting System Yes N/A
ii. Compliance Officer Yes N/A
iii. Risk Manager Yes N/A

5.SIGNATURE OF PRINCIPAL INVESTIGATOR

Report prepared by:

Principal Investigator’s Signature

/ Date
NOTE: The Principal Investigator must sign this form as the individual primarily responsible for the protecting the rights, welfare and safety or subjects and for the conduct of the study.

NSMC Human Research FormUnanticipated Problem/Adverse Event Reporting Form

Version Date: March 2012Page 1 of 2