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A subject received the wrong study drug resulting in severe nausea and vomiting, and a visit to the emergency room for treatment. The subject notified the study coordinator the day after the emergency room visit. The study coordinator reviewed the subject's study records and discovered the error. The coordinator notified the subject of the study drug error, which caused the nausea and vomiting. The investigator notified the IRB and the IRB approved a revision of the standard pharmacy procedure for administering investigational drugs.
A subject received the wrong study drug resulting in severe nausea and vomiting, and a visit to the emergency room for treatment. The subject notified the study coordinator the day after the emergency room visit. The study coordinator reviewed the subject's study records and discovered the error. The coordinator notified the subject of the study drug error, which caused the nausea and vomiting. The investigator notified the IRB and the IRB approved a revision of the standard pharmacy procedure for administering investigational drugs. a) The subject should have contacted the study site for authorization before going to the emergency room.
b) This is an adverse event that was anticipated because there is always a possibility of a pharmaceutical mistake.
c) This is an unanticipated problem, which resulted in an adverse event.
d) The IRB does not have authorization to require changes in the pharmacy procedures
Final answer:The incident with the wrong administration of the study drug was an unanticipated problem, not foresaw, causing an adverse event. The IRB responded promptly to the notification, approving necessary procedure revisions to avoid such disastrous mistakes in future. It's the IRB duty to ensure the subjects' safety in research.Explanation:This situation represents anunanticipated problem, which resulted in anadverse event. Typically, unanticipated problems in a research context are those that were not foreseen and could potentially pose risks to the subjects. In this case, the error made with the study drug was unexpected and had severe effects on the subject. The Institutional Review Board's (IRB) role is to protect the rights and welfare of the subjects. Upon the investigator's notification, they approved a revision to the standard procedure to prevent similar errors in the future. This does not imply that mistakes with pharmaceuticals are anticipated but rather stresses proactive management and handling of such unexpected situations to ensure subject safety.Learn more about Unanticipated Problem in Research here:brainly.com/question/30582007#SPJ4...