Question

A study requires that each subject be given two study drugs. The first study drug is given on Day 1. A second study drug is given on Day 7 to counteract the toxicity of Drug 1. Subject # 4-706 is given Drug 1 on Day 1. Due to a snowstorm, Subject 4-706 is delayed for several days before returning to the site for Drug 2. Missing the administration of Drug 2 on Day 7 placed the subject at risk of significant toxicity. This event required the subject be notified of the increased risk and required close monitoring of the subject by phone. This is an unanticipated problem that does not include an adverse event. This is not an unanticipated problem because adverse weather is a possibility in the area where the site is located. This is an adverse event, which does not require notification to the IRB. This is not an unanticipated problem because the subject was required to return on Day 7.

Answer 1

This is an unanticipated problem because adverse weather leading to a delay in administering Drug 2 for Subject 4-706 was not anticipated during the study planning.

The event placed the subject at an increased risk of significant toxicity, requiring notification to the IRB (Institutional Review Board) and close monitoring of the subject by phone.

Adverse events are typically events that result in harm to the subject, while unanticipated problems refer to any incident, experience, or outcome that was not previously identified or anticipated in the research protocol.

In this case, the weather-related delay qualifies as an unanticipated problem.