NUS Institutional Review Board (IRB)

REPORT OF SERIOUS ADVERSE EVENTS or

UNANTICIPATED EVENTS

[Please use this form to report any adverse or unanticipated event(AE/UE) to NUS-IRB]

Section A: Study Information

NUS-IRB Reference No.: / Date of Report:
Principal Investigator:
Protocol Title:

Section B: Reporting Timeline (Please tick ONE of the boxes)

/ Initial notification to NUS-IRB within 24 working hours / Research resulting in death or potentially life-threatening unexpected SAE. Adverse event is of high risk to research subject.
/ Initial notification to NUS-IRB within 1 week / AE/UE reported is of low risk to research subjects. Subsequent follow-up reports must be made within 3 weeks from initial notification.
/ Follow-Up report(s) / Subsequent reports that follow after the initial report have been submitted to the NUS-IRB. The initial report was submitted to the NUS-IRB on ______(date)

Section C: Details of Adverse or Unanticipated Events

Participant Identifier: / Age (if known): / Gender: Male/Female
Where did the Event occur?
Date PI become aware of this event:
Provide a summary of the event that has occurred in the space below. When appropriate, include the date of event, date of discovery and the outcome (if any). If this is a follow-up report, provide a brief summary of any earlier reports and dates they were submitted to the IRB.
  1. Has participant recruitment ceased? Yes No

  1. Has this type of problem been reported before? Yes No
If Yes, please describe the similar event(s). If appropriate, state how often this type of event has been reported previously and whether you consider the frequency to be unusually high.
  1. Is this type of problem likely to occur again? (Please explain.) Yes No

  1. Is there any follow-up action required by the PI in relation to the problem reported, e.g., on-going communication with participants, etc? Please explain. Yes No

Section D: Changes as a Result of the Problem

  1. Will PI be making any changes to the protocol as a result of this problem? Yes No
(If yes, please submit an application for Protocol Amendment)
  1. Will PI be making any changes to the Consent Documents as a result of this problem?
Yes No
  1. Will PI inform current participants about any of this new safety information?Yes No

  1. In the PI’s judgment, is the overall risk-benefit of this research study still acceptable considering the new information regarding this event? Yes No

  1. This event may constitute (check all that apply):
Unanticipated Problem involving risks to subjects or others
Serious Noncompliance
Continuing Noncompliance
None of the above (please explain):
  1. In the judgment of the PI, was there a relationship between the problem and the research?
Check one.
Definitely – clearly related to the research
Probably – likely related to the research
Possibly – may be related to the research
Probably not – doubtfully related to the research
Definitely not – clearly not related to the research
PI’s Signature: / PI’s Name: / Date:
IRB’s Determination:
The event reported constitutes:
 serious non-compliance;
 continuing non-compliance; and/or
an unanticipated problem involving risks to subjects or others. Corrective action plan appropriate. The IRB requires no further action at this time.
Event acknowledged. Event does not constitute serious or continuing non-compliance or an unanticipated problem involving risk to subjects or others. Reporting to outside agencies not required. The IRB requires no further action at this time.
Signature of Chairman or Designee / Date / Name

IRB-FORM-003Page 4 of 4Version No: 3,5Mar 2013

NUS Institutional Review Board (IRB)

REPORT OF SERIOUS ADVERSE EVENTS or

UNANTICIPATED EVENTS

Glossary of Key Terms[i]

Serious adverse event: Any adverse event temporally associated with the subject’s participation in research that meets any of the following criteria:

  1. results in death;
  2. is life-threatening (places the subject at immediate risk of death from the event as it occurred);
  3. requires inpatient hospitalization or prolongation of existing hospitalization;
  4. results in a persistent or significant disability/incapacity;
  5. results in a congenital anomaly/birth defect; or
  6. any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition (examples of such events include allergic bronchospasm requiring intensive treatment in the emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse).

(Modified from the definition of serious adverse drug experience in FDA regulations at 21 CFR 312.32(a).)

Unexpected adverse event: Any adverse event occurring in one or more subjects in a research protocol, the nature, severity, or frequency of which is not consistent with either:

  1. the known or foreseeable risk of 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 relevant sources of information, such as product labeling and package inserts; or
  2. the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event.

(Modified from the definition of unexpected adverse drug experience in FDA regulations at 21 CFR 312.32(a).)

Unanticipated problem involving risks to subjects or others: Any incident, experience, or outcome that meets all of the following criteria:

  1. unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
  2. related or possibly related to a subject’s participation in the research; and
  3. suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) related to the research than was previously known or recognized.

Possibly related to the research: There is a reasonable possibility that the adverse event, incident, experience or outcome may have been caused by the procedures involved in the research (modified from the definition of associated with use of the drug in FDA regulations at 21 CFR 312.32(a)).

IRB-FORM-003Page 1 of 1Version No: 3, 5 Mar 2013

[i] From