Adverse Event Reporting

All investigators conducting a research study through the TraCS Institute have a responsibility to report problems or adverse events that occur during the research to the IRB (OHRE).

See the OHRE reporting policy for Adverse Events and Unanticipated Problems.

Definitions

  • "Adverse event" or "adverse experience" (AE) is an undesirable and unintended, though not necessarily unanticipated, injury or physical or emotional consequence to a human subject.
  • "Unanticipated Problems" (UPs) may or may not include specific events experienced by individual subjects, but are developments within the research activity that suggest a potential for increased risks to subjects or others.

Adverse Event Grading/Classification Systems

All Adverse Events (AE) should be categorized or graded according to severity. Each protocol may have a unique approach to grading AEs, and the Principal Investigator should consult the master protocol and/or funding source for specific grading scales. Multi-center studies generally include such a table, sometimes called a “toxicity table” in the master protocol. A grading scale or toxicity table that will be used to grade AEs should be included in the Safety Monitoring Plan submitted.

It is strongly recommended that if a protocol does not already have a specific grading scale, the Common Terminology Criteria (CTCAE) scale be utilized. The CTCAE scale is available at ctep.cancer.gov.

An adverse event grading scale of mild-moderate-severe may be used for simple studies. A typical scale and definitions for these terms includes:

  • Mild Adverse Event – Event results in mild or transient discomfort, not requiring intervention or treatment; does not limit or interfere with daily activities (e.g., insomnia, mild headache).
  • Moderate Adverse Event – Event is sufficiently discomforting so as to limit or interfere with daily activities; may require interventional treatment (e.g., fever requiring antipyretic medication).
  • Severe and undesirable Adverse Event – Event results in significant symptoms that prevents normal daily activities; may require hospitalization or invasive intervention (e.g., anemia resulting in blood transfusion).
NOTE: Although not anticipated, adverse events may occur in any study and should be tracked (whether or not reportable) and graded by the investigator or study physician.