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Reporting Adverse Events

If the answer is "yes" to any of the following three questions, the Adverse Event Form (MS Word) must be filled out and submitted for that event:

1. Did or will the event cause harm to the participant or others?
2. Was the event unexpected? 
3. Was the event related to a study procedure?

What is an Adverse Event?

Adverse events occur most commonly in the context of biomedical research, although on occasion, adverse events can occur in the context of social and behavioral research.

Adverse events may be the result of:

1. the interventions and interactions used in the research;
2. the collection of identifiable private information in the research;
3. an underlying disease, disorder, or condition of the subject; and/or
4. other circumstances unrelated to the research or any underlying disease, disorder, or condition of the subject.

In general, adverse events that are at least partially the result of (a) or (b) would be considered related to the research, whereas adverse events solely related to (c) or (d) would be considered unrelated to the research.

For the purposes of guidance, OHRP considers the terms expected and anticipated (and the terms unanticipated and unexpected) to be synonymous. An expected adverse event is an event previously known or anticipated to result from:

1. the interventions and interactions used in the research;
2. the collection of identifiable private information under the research;
3. an underlying disease, disorder, or condition of the human subject; and/or
4. other circumstances unrelated to the research or any underlying disease, disorder, or condition of the subject.

For example, neutropenia and opportunistic infections frequently are adverse events expected to result from chemotherapy administered to subjects participating in an oncology clinical trial.

An unexpected adverse event is an adverse event not previously known or anticipated to result from:

1. the interventions and interactions used in the research;
2. the collection of identifiable private information under the research;
3. an underlying disease, disorder, or condition of the human subject; and/or
4. other circumstances unrelated to the research or any an underlying disease, disorder, or condition of the subject.

An assessment of the significance and expectedness of a particular adverse event or group of adverse events also needs to account for the level of severity and frequency of the adverse events occurring in the subject population (see section III below for further discussion of these concepts).

Download the Adverse Event Form (MS Word)

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