a study requires that each subject be given two study drugs. the first study drug is given on day 1. a…

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 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. 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.

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 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. 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.

Answer

Brief Explanations:

An unanticipated problem is one not foreseen in the study design. The delay due to the snow - storm led to a risk of significant toxicity, which is an adverse event. Such an event that affects the safety of the subject and was not part of the original plan should be reported to the Institutional Review Board (IRB). The other options are incorrect as this is an unanticipated problem with an adverse event. Adverse weather being possible does not mean the resulting risk to the subject was anticipated in terms of study procedures.

Answer:

None of the provided options are correct. This is an unanticipated problem that includes an adverse event and requires notification to the IRB.