REPORT AN UNANTICIPATED PROBLEM OR ADVERSE EVENT

 

Unanticipated problems involves risk to subjects or others and is an incident, experience, or outcome that meets all of the following criteria:

  • It is unexpected in nature, severity and/or frequency;
  • It is related to, or possibly related to, participation in the research; AND
  • It suggests that the research may place subjects or others at greater risk of harm than was previously known.

Unanticipated adverse event means any adverse event occurring in one or more subjects and is not consistent with either:

  • The known or foreseeable risk of adverse events associated with the procedures in the approved protocol; OR
  • The expected natural progression of any underlying disease, disorder or condition of the subject(s).

OTHER CONSIDERATIONS

Data security breaches such as a lost or stolen laptop or lost USB drive may also be considered an unanticipated problem or adverse event since participant data may be compromised and should also be reported to the HSC.

Protocol noncompliance or deviations, such as not adhering to the approved protocol may also be considered an unanticipated problem or adverse event and should also be reported to the HSC. Examples of protocol noncompliance or deviations may include, but are not limited to:

  • Failure to follow the approved protocol procedures;
  • Failure to obtain prospective HSC review for additional research related activities not covered under the approved protocol such as adding a new study population, recruitment method, new measures or study procedures;
  • Failure to obtain and/or document informed consent, unless a waiver is approved.



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WHEN DO I REPORT AN UNANTICIPATED PROBLEM OR ADVERSE EVENT?

Investigators are expected to report an unanticipated problem or adverse event when they are: 1) unexpected; 2) related or possibly related to participation in the study; and 3) suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized.

An unanticipated problem that is serious in nature should be reported to the HSC within one (1) week of the investigator becoming aware of the event.

HOW DO I SUBMIT A REPORT OF AN UNANTICIPATED PROBLEM OR ADVERSE EVENT?

Contact the HSC by email or by phone at (805) 893-3807 to submit an initial report of an unanticipated problem or adverse event.

For more specifics on reporting requirements, see HSC SOP 023 Unanticpated Problems or Adverse Events.