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 give
n 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 considered an unexpected problem without an adverse event.
Explanation:
During scientific research many variables must be considered, but not only during laboratory testing.
Many times we may have unforeseen events in the subject's life, such as delays, accidents or not following the protocol required by the tests.
In this case there was a lack of monitoring of the subject that could have been done by phone or even email, it is important to anticipate any possible event that disrupts the research, as it could cost the lives of people.
