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).
- "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).