clinical research and GCP IV …Case Study:Adverse Event Scenario

Adverse Event Scenario 2

 A patient in a clinical trial is called in for an elective bunion removal operation. The patient was on the waiting list prior to entering the trial and a cancellation has meant that she is able to have the operation sooner than expected. The operation goes smoothly and the patient appears to be making a good recovery.The patient attends for a study visit and on the way into the hospital she trips and bangs the foot, which causes the wound to bleed. At the next visit the foot is badly bruised and the wound is weeping. The patient is having to attend outpatient clinics to have the wound cleaned and dressed more frequently than would normally have been the case post-operative, but the stitches are intact. The long term outcome is that the foot takes two weeks longer to heal than the standard healing time.

Which of the following are Adverse Events or Serious Adverse Events?

The bunion

•  Not an Adverse Event
•  Adverse Event
•  Serious Adverse Event

The operation

•  Not an Adverse Event
•  Adverse Event
•  Serious Adverse Event

The trip

•  Not an Adverse Event
•  Adverse Event
•  Serious Adverse Event

The damage to the wound

• Not an Adverse Event
• Adverse Event
• Serious Adverse Event