Complete Question:
A study requires that each subject be given two study drugs. The firststudy 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.
Answer:
The problem was unanticipated and no adverse event was recorded.
Step-by-step explanation:
The researchers didn’t anticipate a weather problem that would’ve affected their study, hence the delay in administering drug 2. Although no adverse event was recorded, they were right to have closely monitored the subject. The situation must be reported to the authorities.