Housekeeping employees of the medical center were recruited for a federally funded study of blood pressure, blood count levels,
infectious disease history, and job stress. The interviews and blood tests were conducted in a private location not affiliated with the study center. Follow-up interviews were conducted in the same location. The study coordinator stopped at the cafeteria on her way back to the study office after the second study visit for the last three study subjects and lost the three file folders. Records of one subject indicated he had a history of a sexually transmitted disease and another had recently been treated for tuberculosis. The subjects were notified of the loss. Following this event, the IRB approved a protocol change requiring that all records be transmitted electronically to the study office using the medical center's secure network. -This is an unanticipated problem and not an adverse event.
-This is not an unanticipated problem because employees' medical records are on file in the medical center.
-The coordinator should assume that housekeeping staff will locate the files and return them to her at the end of the day.
-This is not an unanticipated problem nor an adverse event because it is not a clinical trial.
This is an unanticipated problem and not an adverse event.
Explanation:
An unanticipated problem is one that happens in an unexpected and surprising way, where the individuals involved did not have any strategy to solve it, since they did not imagine that this problem would occur. An adverse event, on the other hand, represents a medical occurrence that occurred with an individual after he ingested a certain pharmaceutical product that caused an adverse reaction in his body.
As we can see in the question above, the study coordinator stopped at the cafeteria and lost the three file folders that contained information about the study participants. As a result, the coordinator did not learn that one of the participants had a history of a sexually transmitted disease and another had recently been treated for tuberculosis. This is not an adverse event, but an unanticipated problem.
