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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:

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

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:

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.

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