Respuesta :
The human error in the screening process is an unanticipated problem requiring notification to the IRB and FDA
A clinical trial is a carefully monitored experiment conducted on human volunteers to evaluate the efficacy and safety of interventions or therapies for any illnesses or other health issues. Finding out how new treatments will affect pharmacologically, pharmacokinetically, and pharmacodynamically includes researching negative effects. In addition to the requirement for a suitable and regulated setting, this experiment also necessitates the use of medical equipment.
In hospitals or medical clinics, clinical trials are typically conducted. Clinical trials are tests or studies conducted for medical research. These experiments help researchers formulate theories. Clinical trials are a type of human participant-based, prospective biomedical or behavioral research study that aims to provide answers to particular questions concerning biomedical or behavioral interventions, including novel therapies.
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The complete question is -
An investigational biologic administered to the first two subjects in a Phase II clinical trial was not appropriately screened for two viral contaminants, HIV and Hepatitis B, due to human error in the screening process. Follow-up testing indicated that the subjects and their partners were not infected. The subjects and others were notified of the increased risk.
